Simple control of complex bio-implants

ABSTRACT

Methods and devices for tying management of an implantable medical device to the activities of a primary care physician are described, including access control, simplified parameter optimization, support for tuning a device in response to the effects of other treatments in parallel, and support for helping a primary physician and a patient work together to tune device configuration to the activity and performance needs of the patient. In some embodiments, a medical device is self-configuring in a device parameter domain, based on inputs provided in a patient performance domain. The self-configuring of the medical device is based, for example, on an automatically applied transformation of inputs derived from patient performance domain observations into changes in the configuration of the medical device which affect technical parameters of its operation.

RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.16/257,125 filed on Jan. 25, 2019, which is a continuation of U.S.patent application Ser. No. 15/190,451 filed on Jun. 23, 2016, whichclaims the benefit of priority under 35 USC 119(e) of U.S. ProvisionalPatent Application No. 62/183,847 filed on Jun. 24, 2015, the contentsof which are incorporated herein by reference in their entirety.

FIELD AND BACKGROUND OF THE INVENTION

The present invention, in some embodiments thereof, relates toimplantable medical devices and methods and, more particularly, but notexclusively, to devices having complex configuration profiles, whichpotentially require or benefit from periodic reconfigurations over anextended period of use.

Some classes of implantable medical devices, including pacemakers,defibrillators, neurostimulators and contractility modulation IPG(implantable pulse generator) devices, include programmable features bywhich an attending doctor adjusts device function. Setup parametersinclude those for initial device configuration, and/or adjustment tochanging patient needs. Some setup parameters dynamically govern deviceresponse to sensed information provided to and/or by the device. Someimplantable devices log performance and/or sensed data for simultaneousand/or off-line analysis by a physician.

Some of today's devices offer interfaces that contain over hundreddifferent parameters. It is potentially necessary to change many of themat once to bring about a functional adjustment. Moreover, the effects ofdifferent parameters potentially interact with one another, increasingconfiguration complexity. Device function optionally adjusts accordingto changing patient status and condition.

The device may include sensing functions and/or interface with sensingdata, based upon which device function may self-adjust.

Programmable parameters are typically configured in terms of technicallydefined quantities, for example, voltage, impedance, electrodecharacteristics, rate of change (slope/first derivative), rate of rateof change (slope of rate of change/second derivative), maximum rate,energy to be delivered, and/or thresholds defining events.

SUMMARY OF THE INVENTION

According to an aspect of some embodiments of the present invention,there is provided a method of adjusting the operation of an implantablemedical device, comprising: receiving access to selectively activatefrom among a plurality of technical parameter sets preconfigured for usewith the implantable medical device, wherein the parameter sets areordered according to their effect on a clinical parameter affected byoperation of the device; monitoring the response of the clinicalparameter to activation of a first of the preconfigured parameter setsordered between at least two others of the preconfigured parameter sets;and activating one of the other two preconfigured parameter sets, basedon the ordering of the parameter sets, the monitoring of the clinicalparameter and a clinical target for the clinical parameter.

According to some embodiments of the invention, receiving accesscomprises presenting the device with an access token accepted by thedevice.

According to some embodiments of the invention, the plurality oftechnical parameter sets was preconfigured after implantation of theimplantable medical device within a patient.

According to some embodiments of the invention, the clinical parametercomprises a clinical measure of patient performance

According to some embodiments of the invention, the clinical parametercomprises self-reported patient performance

According to some embodiments of the invention, the parameter sets areordered according to a therapeutic effect of the device.

According to some embodiments of the invention, the parameter sets areordered according to a side-effect of the device.

According to some embodiments of the invention, the implantable medicaldevice is a stimulator configured for cardiac contractility modulation.

According to some embodiments of the invention, the implantable medicaldevice is a stimulator configured for gastric contractility modulation.

According to some embodiments of the invention, the implantable medicaldevice is an implanted pulse generator configured for central nervoussystem stimulation.

According to some embodiments of the invention, the implantable medicaldevice is a stimulator configured for cardiac resynchronization therapy.

According to some embodiments of the invention, the plurality oftechnical parameter sets are configured by a device implantationspecialist, and the receiving access is by a primary medical careprovider.

According to some embodiments of the invention, the preconfiguredparameter sets are stored by the implantable medical device.

According to some embodiments of the invention, the method comprisescontinued monitoring of the response of the clinical parameter, andactivating of other parameter sets based on the ordering of theparameter sets and as indicated by the state of the monitored clinicalparameter relative to the clinical target.

According to some embodiments of the invention, the continued monitoringends when the clinical parameter reaches the clinical target.

According to an aspect of some embodiments of the present invention,there is provided a method of associating an implanted medical device toa non-implanting referring health care provider, comprising: providingthe referring health care provider with a device access key; configuringthe implanted medical device to allow at least one function of thedevice to be controlled based on identification of the device accesskey.

According to some embodiments of the invention, the at least oneaccessible function includes selection from a plurality of technicalparameter sets preconfigured for use with the implantable medicaldevice.

According to some embodiments of the invention, the configuringcomprises receiving an identifier of the device access key from thereferring health care provider, and configuring the device to recognizethe identifier.

According to some embodiments of the invention, the configuringcomprises the referring health care provider configuring the device torecognize an identifier of the device access key.

According to some embodiments of the invention, the at least oneaccessible function comprises activation of an inactive treatmentfunction of the implanted medical device.

According to some embodiments of the invention, the method compriseslocking the device to inactivate the inactive treatment function untilaccessed by the device access key.

According to some embodiments of the invention, the device access keycomprises a charging mechanism for charging the implanted medicaldevice.

According to some embodiments of the invention, the device access key islimited in a number of uses.

According to some embodiments of the invention, the device access keycomprises an alphanumeric code.

According to some embodiments of the invention, the device access keycomprises a cryptographic key.

According to an aspect of some embodiments of the present invention,there is provided an implantable medical device system supportingconfiguration by a primary care physician, comprising: a data storeconfigured to receive and store a plurality of inactive technicalparameter sets for use with the implantable medical device; and aselection interface for selecting from among the inactive technicalparameter sets and activating at least one of them; wherein theimplanted medical device provides access allowing parameter setactivation based on recognition of an access key.

According to some embodiments of the invention, the data store indexesthe technical parameter sets according to a parameter of their effect onpatient performance, and the selection interface presents inactivetechnical parameter sets for selection according to the index.

According to some embodiments of the invention, the data store isintegrated with the implanted medical device.

According to some embodiments of the invention, the access key does notgive access to modify the inactive technical parameter sets of the datastore.

According to some embodiments of the invention, the access key comprisesan alphanumerically represented key.

According to some embodiments of the invention, the access key comprisesa cryptographic key.

According to some embodiments of the invention, the access key comprisesa charger device.

According to some embodiments of the invention, the access key comprisesthe data store.

According to some embodiments of the invention, operation of theselection interface comprises entering data about the operation ofanother implantable medical device of the patient.

According to some embodiments of the invention, operation of theselection interface comprises entering data about a medicamentprescription of the patient.

According to an aspect of some embodiments of the present invention,there is provided an implantable medical device configured to allow atleast one functional profile of the device to be controlled based onidentification of a device access key, wherein the device access keygrants exclusive access to the functional profile.

According to some embodiments of the invention, control of thefunctional profile of the device is available based on identification ofthe device access key.

According to an aspect of some embodiments of the present invention,there is provided a method for associating a primary care physician to apatient having an implanted medical device comprising: referring thepatient from the primary care physician to an implanting physician forimplanting the implanted medical device; presenting a device access key,thereby obtaining exclusive access to the functions of a functionalprofile of the implanted medical device after implantation; operating anexclusively accessed function of the implanted medical device to changean operating parameter of the implanted medical device.

According to an aspect of some embodiments of the present invention,there is provided an implantable medical device configured to convertfrom an unmanaged post-implantation state to a managed post-implantationstate upon activation of a state changing function by a primary carephysician, wherein the managed post-implantation state allows activationof a treatment function not available in the unmanaged post-implantationstate.

According to some embodiments of the invention, the activation comprisespresenting an access key to the implantable medical device.

According to some embodiments of the invention, the activation comprisesactivating a channel reserved for use by a primary care physician.

According to some embodiments of the invention, the device provides anaccess key to the physician upon activation of the channel, andthereafter allows activation of the treatment function based onpresentation of the access key.

According to an aspect of some embodiments of the present invention,there is provided a method of setting a plurality of technical domainparameters of an operating configuration of an implanted medical device,the method comprising: receiving a selection input indicating a targetstate of at least one parameter in a patient performance domain;converting the selection input to settings of the technical domainparameters; and storing the settings of the technical domain parametersas the operating configuration of the implanted medical device.

According to some embodiments of the invention, the converting comprisesselection of technical domain parameters based on observed correlationsof operating configurations with effects in the patient performancedomain.

According to some embodiments of the invention, the converting comprisesusing the selection input to select from a data structure comprising aplurality device configuration options.

According to some embodiments of the invention, the selection inputindicates the target state by specification of a direction of change fora value of the at least one parameter in the patient performance domain.

According to some embodiments of the invention, the selection inputindicates a plurality of the directions of change for values of acorresponding plurality of parameters of the at least one parameter inthe patient performance domain.

According to some embodiments of the invention, the converting comprisesadjustment of a greater number of parameters in the technical domainthan the number of parameters indicated in the patient performancedomain by the selection input.

According to some embodiments of the invention, the at least oneparameter in the patient performance domain comprises a parametercorrelated with the production of a therapeutic effect in the patient bythe implanted medical device.

According to some embodiments of the invention, the at least oneparameter in the patient performance domain comprises a parametercorrelated with the production of a side effect in the patient by theimplanted medical device.

According to some embodiments of the invention, the selection inputcomprises indication of a relative balance of the therapeutic effect andthe side effect. According to some embodiments of the invention, theconverting comprises selecting an at least partially predefined deviceconfiguration from the device configuration option data, based on thereceived selection input.

According to some embodiments of the invention, the method comprisesrepeating the receiving, converting, and storing after a time intervalduring which the at least one parameter in the patient performancedomain changes to reflect operation of the implanted medical deviceunder control of the previously stored operating configuration.

According to an aspect of some embodiments of the present invention,there is provided a method of setting an operating configuration of animplanted medical device for production of a therapeutic effect in apatient, the method comprising: evaluating of a current state of atleast one parameter in a patient performance domain; determining atarget state of the at least one parameter, based on the evaluating; andproviding a machine-encoded selection input indicating the determinedtarget state for conversion into a plurality of technical domainparameter settings defining an operating configuration of the implantedmedical device.

According to some embodiments of the invention, the at least oneparameter in the patient performance domain comprises a parametercorrelated with the production of a therapeutic effect in the patient bythe implanted medical device.

According to some embodiments of the invention, the at least oneparameter in the patient performance domain comprises a parametercorrelated with the production of a side effect in the patient by theimplanted medical device.

According to some embodiments of the invention, the selection inputcomprises an indication of a relative balance of the therapeutic effectand the side effect.

According to some embodiments of the invention, the conversion comprisesselecting an at least partially predefined device configuration from thedevice configuration option data, based on the received selection input.

According to an aspect of some embodiments of the present invention,there is provided a method of customizing a plurality of configurationoptions of an medical device implanted in a patient, the methodcomprising: determining correlations between a plurality of operatingconfigurations of the device and a corresponding plurality of states ofat least one patient performance parameter; generating deviceconfiguration option data, based on the determined correlations, thedevice configuration option data being structured to allow selection ofan operating configuration option from an indication of a target stateof the at least one patient performance parameter; and storing thedevice configuration option data for use in determination of an actualoperating configuration of the implanted medical device, based onselection input indicating a target state of the at least one patientperformance parameter.

According to some embodiments of the invention, the method comprisesstoring an actual operating configuration of the implanted medicaldevice, based on selection input indicating the target state and thedevice configuration option data; comparing an actual state of the atleast one patient performance state to the target state, the actualstate being obtained after the determination of the operatingconfiguration, and updating the device configuration option data, basedon the comparing.

According to some embodiments of the invention, the determiningcomprises both: determining some of the correlations individually forthe patient, and additional selection of the correlations from one ormore previously determined correlations between operating configurationsand patient performance parameter states; and the generating comprisesusing correlations determined individually for the patient as referencesto map the additionally selected correlations to the patient performanceparameter states of the patient.

According to an aspect of some embodiments of the present invention,there is provided a kit for configuration of an implantable medicaldevice, the kit comprising: A data store configurable to store deviceconfiguration option data customized for a patient to indicatecorrelations between device configuration options and at least onepatient performance parameter; A device parameter store configurable todefine an operating configuration of the implantable medical device; anda configuration selector, operable to: receive selection inputindicating a target state of the at least one patient performanceparameter, define an operating configuration of the implantable medicaldevice, based on the received selection input and the deviceconfiguration option data in the data store, and provide the definedoperating configuration to the device parameter store.

According to some embodiments of the invention, the implantable medicaldevice comprises the parameter store, and the configuration selector.

According to some embodiments of the invention, the implantable medicaldevice at least partially comprises the data store.

According to some embodiments of the invention, the implantable medicaldevice entirely comprises the data store.

According to some embodiments of the invention, operation of theconfiguration selector to define the operating configuration comprisesselecting an at least partially predefined configuration from the deviceconfiguration option data, based on the received selection input.

According to some embodiments of the invention, operation of theconfiguration selector to define the operating configuration comprisesdefining a parameter of the operating configuration, based on thereceived selection input.

According to some embodiments of the invention, the indicated targetstate comprises an increase or decrease in a value measuring the atleast one patient parameter.

According to some embodiments of the invention, the selection inputindicates the target state by specification of a direction of change fora value of the at least one parameter in the patient performance domain.

According to some embodiments of the invention, the system comprises aninterface device, configured to receive user input indicating the targetstate of the at least one patient performance parameter, andelectronically communicate this as the selection input to theconfiguration selector.

According to some embodiments of the invention, operation of theconfiguration selector to define the operating configuration comprisesselecting an at least partially predefined configuration from the deviceconfiguration option data, based on the received selection input.

Unless otherwise defined, all technical and/or scientific terms usedherein have the same meaning as commonly understood by one of ordinaryskill in the art to which the invention pertains. Although methods andmaterials similar or equivalent to those described herein can be used inthe practice or testing of embodiments of the invention, exemplarymethods and/or materials are described below. In case of conflict, thepatent specification, including definitions, will control. In addition,the materials, methods, and examples are illustrative only and are notintended to be necessarily limiting.

As will be appreciated by one skilled in the art, aspects of the presentinvention may be embodied as a system, method or computer programproduct. Accordingly, aspects of the present invention may take the formof an entirely hardware embodiment, an entirely software embodiment(including firmware, resident software, micro-code, etc.) or anembodiment combining software and hardware aspects that may allgenerally be referred to herein as a “circuit,” “module” or “system.”Furthermore, some embodiments of the present invention may take the formof a computer program product embodied in one or more computer readablemedium(s) having computer readable program code embodied thereon.

Implementation of the method and/or system of some embodiments of theinvention can involve performing and/or completing selected tasksmanually, automatically, or a combination thereof. Moreover, accordingto actual instrumentation and equipment of some embodiments of themethod and/or system of the invention, several selected tasks could beimplemented by hardware, by software or by firmware and/or by acombination thereof, e.g., using an operating system.

For example, hardware for performing selected tasks according to someembodiments of the invention could be implemented as a chip or acircuit. As software, selected tasks according to some embodiments ofthe invention could be implemented as a plurality of softwareinstructions being executed by a computer using any suitable operatingsystem. In an exemplary embodiment of the invention, one or more tasksaccording to some exemplary embodiments of method and/or system asdescribed herein are performed by a data processor, such as a computingplatform for executing a plurality of instructions. Optionally, the dataprocessor includes a volatile memory for storing instructions and/ordata and/or a non-volatile storage, for example, a magnetic hard-diskand/or removable media, for storing instructions and/or data.Optionally, a network connection is provided as well. A display and/or auser input device such as a keyboard or mouse are optionally provided aswell.

Any combination of one or more computer readable medium(s) may beutilized for some embodiments of the invention. The computer readablemedium may be a computer readable signal medium or a computer readablestorage medium.

A computer readable storage medium may be, for example, but not limitedto, an electronic, magnetic, optical, electromagnetic, infrared, orsemiconductor system, apparatus, or device, or any suitable combinationof the foregoing. More specific examples (a non-exhaustive list) of thecomputer readable storage medium would include the following: anelectrical connection having one or more wires, a portable computerdiskette, a hard disk, a random access memory (RAM), a read-only memory(ROM), an erasable programmable read-only memory (EPROM or Flashmemory), an optical fiber, a portable compact disc read-only memory(CD-ROM), an optical storage device, a magnetic storage device, or anysuitable combination of the foregoing. In the context of this document,a computer readable storage medium may be any tangible medium that cancontain, or store a program for use by or in connection with aninstruction execution system, apparatus, or device.

A computer readable signal medium may include a propagated data signalwith computer readable program code embodied therein, for example, inbaseband or as part of a carrier wave. Such a propagated signal may takeany of a variety of forms, including, but not limited to,electro-magnetic, optical, or any suitable combination thereof. Acomputer readable signal medium may be any computer readable medium thatis not a computer readable storage medium and that can communicate,propagate, or transport a program for use by or in connection with aninstruction execution system, apparatus, or device.

Program code embodied on a computer readable medium and/or data usedthereby may be transmitted using any appropriate medium, including butnot limited to wireless, wireline, optical fiber cable, RF, etc., or anysuitable combination of the foregoing.

Computer program code for carrying out operations for some embodimentsof the present invention may be written in any combination of one ormore programming languages, including an object oriented programminglanguage such as Java, Smalltalk, C++ or the like and conventionalprocedural programming languages, such as the “C” programming languageor similar programming languages. The program code may execute entirelyon the user's computer, partly on the user's computer, as a stand-alonesoftware package, partly on the user's computer and partly on a remotecomputer or entirely on the remote computer or server. In the latterscenario, the remote computer may be connected to the user's computerthrough any type of network, including a local area network (LAN) or awide area network (WAN), or the connection may be made to an externalcomputer (for example, through the Internet using an Internet ServiceProvider).

Some embodiments of the present invention may be described below withreference to flowchart illustrations and/or block diagrams of methods,apparatus (systems) and computer program products according toembodiments of the invention. It will be understood that each block ofthe flowchart illustrations and/or block diagrams, and combinations ofblocks in the flowchart illustrations and/or block diagrams, can beimplemented by computer program instructions. These computer programinstructions may be provided to a processor of a general purposecomputer, special purpose computer, or other programmable dataprocessing apparatus to produce a machine, such that the instructions,which execute via the processor of the computer or other programmabledata processing apparatus, create means for implementing thefunctions/acts specified in the flowchart and/or block diagram block orblocks.

These computer program instructions may also be stored in a computerreadable medium that can direct a computer, other programmable dataprocessing apparatus, or other devices to function in a particularmanner, such that the instructions stored in the computer readablemedium produce an article of manufacture including instructions whichimplement the function/act specified in the flowchart and/or blockdiagram block or blocks.

The computer program instructions may also be loaded onto a computer,other programmable data processing apparatus, or other devices to causea series of operational steps to be performed on the computer, otherprogrammable apparatus or other devices to produce a computerimplemented process such that the instructions which execute on thecomputer or other programmable apparatus provide processes forimplementing the functions/acts specified in the flowchart and/or blockdiagram block or blocks.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

Some embodiments of the invention are herein described, by way ofexample only, with reference to the accompanying drawings. With specificreference now to the drawings in detail, it is stressed that theparticulars shown are by way of example, and for purposes ofillustrative discussion of embodiments of the invention. In this regard,the description taken with the drawings makes apparent to those skilledin the art how embodiments of the invention may be practiced.

In the drawings:

FIG. 1A is a schematic block diagram representing interactions among apatient, an implanted medical device, a primary care physician and/orclinic, and an implanting physician and/or clinic, according to someexemplary embodiments of the invention;

FIG. 1B is a schematic flowchart of how a primary care physician(MD^(P)) interacts with an implantable medical device, according to someexemplary embodiments of the invention;

FIG. 1C schematically represents the relationship of healthcare andother services relative to a patient and a device, according to someexemplary embodiments of the invention;

FIG. 1D schematically represents the relationship of controllers,sensors, and other components of a system supporting management of animplantable medical device, according to some exemplary embodiments ofthe invention;

FIG. 2A is a schematic flowchart representing different domains forimplantable medical device management, according to some exemplaryembodiments of the invention;

FIG. 2B is a schematic flowchart representing modes and operations of animplantable medical device, with respect to an implanting physicianand/or clinic, a primary care physician and/or clinic, and a patient,according to some exemplary embodiments of the invention;

FIG. 3 is a schematic diagram representing interactions among a primarycare physician and/or clinic, a patient, a first implanted medicaldevice, one or more additional devices, and medicaments, according tosome exemplary embodiments of the invention;

FIG. 4 schematically represents the relationship of different access keytypes to an implantable medical device and/or a coordinating service,according to some exemplary embodiments of the invention;

FIG. 5 schematically represents relationship among components of animplantable medical device system, from both the perspective offunctional modules, and from the perspective of system componentsimplementing the functional modules, according to some exemplaryembodiments of the invention;

FIG. 6 is a schematic flowchart of a patient moving through thelife-cycle of an implantable medical device, according to some exemplaryembodiments of the invention.

FIG. 7A is a schematic diagram of an implantable medical device which isselectably configured to produce therapeutic effects via a treatmentmodality over one or more physiological parameters; optionally based onpatient performance sensed by a sensing modality, according to someembodiments of the present disclosure;

FIG. 7B is a schematic diagram of a system for configuring the deviceconfiguration option data of an implanted medical device, according tosome exemplary embodiments of the present disclosure;

FIG. 8A schematically represents a parameter space of potential medicalimplant device parameter configurations, from which members of a subsetof available configurations are selectable according to an orderedarrangement of the configurations along a parametric function, accordingto some embodiments of the present disclosure;

FIGS. 8B, 8C, 8D and 8E schematically represent a medical implant deviceparameter space and some particular implant device configurations withinit, together with indications of relative magnitudes of targetedtreatment effects and/or of preferably avoided side effects withindifferent regions of the parameter space, according to some embodimentsof the present disclosure;

FIGS. 8F-8G schematically represent two-dimensional control spaces,according to some embodiments of the present disclosure;

FIG. 9A is a flow chart representing a configuration life cycle of animplantable medical device, according to some embodiments of the presentdisclosure;

FIG. 9B is a flow chart representing a more particular configurationlife cycle of an implantable medical device, according to someembodiments of the present disclosure;

FIG. 10 is a flowchart that schematically represents operations ofpatient performance evaluation, according to some embodiments of thepresent disclosure;

FIG. 11A is a flowchart that schematically represents a method ofsetting available configuration options for an implantable medicaldevice, according to some embodiments of the present disclosure;

FIG. 11B is a flowchart that schematically represents a method ofupdating available configuration options for an implantable medicaldevice, according to some embodiments of the present disclosure; and

FIG. 12 schematically represents conversion of a default mapping ofdevice parameter space to patient performance space to a mappingapplicable to a particular patient, according to some embodiments of thepresent disclosure.

DESCRIPTION OF SPECIFIC EMBODIMENTS OF THE INVENTION

The present invention, in some embodiments thereof, relates toimplantable medical devices and methods and, more particularly, but notexclusively, to devices having complex configuration profiles, whichpotentially require or benefit from periodic reconfigurations over anextended period of use.

Overview

A broad aspect of some embodiments of the invention relates to theassignment of implantable medical device management responsibilities toprimary care physicians.

In some embodiments, an implanted medical device comprises a largenumber of parameters (for example, 100, 200, 500, 600, or anothergreater, lesser or intermediate number) that need to be configured forcorrect device function.

Optionally, parameters interact, so that settings are adjusted forseveral parameters in concert. Optionally, the device is an implantablemedical device providing one or more modalities of controlledstimulation (ultrasonic, thermal, electrical, electromagnetic, and/ormagnetic stimulation, for example). Examples of stimulus sites are foundthroughout the body, and include the central nervous system (brain andspinal cord, for example), the peripheral nervous system (the vagusnerve and other cranial and spinal nerves), organs of the endocrinesystem, the heart, the stomach, and the kidneys. Stimulation treatmentsinclude treatments for pain control, affective disorders, cardiacfibrillation, heart failure, cardiac rhythm disorders, diabetes,diabetic obesity, and/or obesity. Parameters of stimulus devicesoptionally include numerous parameters of, for example, stimulusstrength, duration, interval, and/or pulse count. Optionally, any ofthese is dynamically dependent on physiological parameters, for exampleas sensed directly by and/or externally provided to the device.

Optionally, an implanted medical device is a non-stimulatory device (forexample, a ventricular assist device) Implanted medical devicesoptionally sense one or more physiological parameters, for example, insupport of a treatment, and/or as a primary function Implanted devicesare optionally configurable to deliver a plurality of treatments.

Device complexity tends to exclude non-specialists from meaningfullyintegrating medical device management into clinical practice. However,primary care physicians are a potentially underutilized resource for themanagement of such medical devices.

In some embodiments, implanted device features support aspects of anoverall clinical system in which primary care physicians assume a morecentral role in implantable device management. Potentially, thiscomprises increased referrals by primary care physicians for implantedmedical device treatments. Increased referrals could be based, forexample, on a primary care physician's greater familiarity with theeffects of the devices, and/or on the understanding that a patient willreturn with options for primary care treatment increased by the newdevice, rather than as a patient with a device that leaves the primarycare provider partially excluded from the clinical picture.

An aspect of some embodiments of the invention relates to implantedmedical devices configured with at least one channel of control and/ormonitoring for use by a primary care provider (for example, a primarycare physician, and/or primary care clinic and its staff). Optionally,the channel is dedicated for use by a primary care provider.

In some embodiments, functions accessed by this channel include, forexample, pre-prepared device parameter settings and/or methods ofselecting from among them, device functioning and/or sensing reportsformatted to assist primary care treatment planning, features that helpthe primary care physician to balance device-delivered treatments withother ongoing treatments and their effects, and/or features thatfacilitate communication between a primary care physician and specialisthealth care providers.

In some embodiments, a device comprises a channel of control designatedfor use by a primary care physician. Optionally, the channel isconfigured for primary care use by a device implanter and/or clinic, forexample during initial device setup at the time of implantation. In someembodiments, other channels are provided for use by, for example, apayer (such as insurer or HMO) or medical specialist. In someembodiments, the group of functions available through a channel ofcontrol comprise a functional profile.

In some embodiments, control by the primary care provider is in a“patient performance domain”, wherein device domain parameters (“lowlevel” parameters) are set in concert (for example, by selecting apredefined parameter set, or otherwise set without detailedspecification of device operation) according to measurements and/orindications of observed and/or intended medical results. For example,balancing a therapeutic effect of a device with side-effects affectslarge number of parameters in the device domain. In some embodiments,control of this balance is by selecting “larger therapeutic effect” or“less side-effects”, while the detailed parameter adjustments at thedevice parameter level are transparent to the primary care provider;performed, for example, according to some predetermined and/or previouscalibrated scheme. A predefined parameter set optionally includes anyfull or partial group of settings which specify device domainparameters, but is not necessarily active on the implanted device.

A predefined parameter set is optionally predefined by specifying one ormore ranges along which parameters are allowed to vary.

Optionally, a predefined parameter set is associated with an expectedclinical effect, for example, an effect on a clinical parameter. Herein,the term “clinical parameter” is used interchangeably with the term“patient performance parameter” to optionally include any clinicalobservation of a patient; for example, a test result to (e.g.,metabolite level, imaging data, and/or monitoring data), a symptom,and/or another clinical finding. The expected clinical effect isoptionally specified at least in part with respect to another predefinedparameter set. For example, a therapeutic effect, side-effect, rate,and/or concentration is expected to be larger or smaller than thecorresponding metric for another parameter set. Optionally, theexpectation is only that there is a difference, according to an orderingof the parameter sets. For example, of three or more parameter setswhich comprise a monotonic change in one or more parameters, a middleone is optionally “larger” in an effect on some clinical parameter thaneither of the other parameter sets.

In some embodiments, control by the primary care provider is in anotherdomain abstracted from the lowest-level device parameter domain. Forexample, a device is set up to deliver “doses” of a therapy, and controlby the primary care physician comprises, for example, choosing aparticular dose “formulation” (parameter setup), number of dosedeliveries, and/or frequency of dose delivery.

In some embodiments, a plurality of predetermined options correspondingto potential treatment outcomes is defined, each choice entailingdifferent device domain parameters; and selection from within the rangeis allowed to a primary care provider. This is a potential advantage touse the relatively detailed knowledge a primary care provider has of apatient's health, without requiring detailed knowledge of the deviceitself.

In some embodiments, a primary care provider guides and/or monitors“A-B” type optimizations of device parameters. In some embodiments,there is a plurality of setting ranges each varying between differentmeasures of, for example, patient performance, side-effects, and/ortherapeutic effects. Optionally, the choice of which range should beadjusted is given to the primary care physician.

An aspect of some embodiments of the invention relates to implantedmedical devices configured to provide controlled access to a primarycare provider.

In some embodiments of the current invention, implanted medical devicefeatures link a primary care provider (a physician, a clinic, or anothermedical provider) to an implantable medical device. Optionally, the linkcomprises granting a primary care provider identifier-controlled accessto one or more of the device functions. Optionally, theidentifier-controlled access is exclusive to a particular primary careprovider (group or individual). Optionally, the link comprises use bythe primary care physician of a device or system component (for example,a device charger, or a data store containing device configuration data).

In some embodiments, primary care management of a device requires use ofa designated access control number or device (such as a password,identifying numeric key, physical device, or another access controltoken). Herein, any such access control token is interchangeablyreferred to as a “key”.

Different regimes of access control comprise embodiments of theinvention. In some embodiments, only a primary care provider who has akey issued by the implanting physician is able to access the device as aprimary care provider.

A potential advantage of such access control is to allow an implantingphysician to maintain quality control and/or monitoring over thethird-party operation (for example, operation by a primary carephysician) of devices for which the implanting physician is responsible.Keys are optionally issued per device and/or per device group (forexample, all devices implanted by a particular implanting physician).Alternatively, a key is initially assigned by a referring primary carephysician, and assigned to the device by the device implanter.

Additionally or alternatively, a primary care physician uses an existingkey to “unlock” a device when a patient comes under the care of hisclinic, thereby assuming access to an available control interface.Optionally, an exclusive association is enforced, unless, for example,unless the original implanter removes association. In some embodiments,in particular, a functional profile comprising functions for use by aprimary care provider is exclusively available in response torecognition of a single key.

Alternatively, any physician possessed of an appropriate key can accessthe device. Optionally, a physician is able to determine whether anotherphysician is accessing the device. Exclusive and/or verified access is apotential advantage, in that a primary care physician becomes thereby“attached” to the device (potentially promoting traceability and/orconsistency of care, for example). In some embodiments, for example,with devices that supply an elective treatment, primary care physicianaccess control provides a mechanism for dose regulation.

For example, a patient purchases a treatment regime that is supplied,monitored and/or adjusted based on access provided by a particular keyand/or key group.

In some embodiments, another arrangement for providing and controllingphysician access to a device is made. Optionally, the degree ofexclusivity provided by the access mechanism is chosen according to anyappropriate combination of controlling conditions, for example, market,liability, and/or regulatory conditions.

An aspect of some embodiments of the current invention relates tocontrol of an implanted medical device based on the administration ofanother synergistic antagonistic, or otherwise interacting auxiliarytreatment (“auxiliary treatment” as used herein means any treatment thatis not that of the implanted medical device itself, and does not implythat the implanted medical device therapy be dominant to the othertreatment).

In some embodiments of the invention, an implanted medical device isprovided with one or more alternate device parameter sets that arecalibrated to alter delivery of a device therapy in response to measuredand/or predicted therapeutic and/or side effects of one or more othertreatments (auxiliary treatments). Selection and/or tuning of parametersets is performed by the primary care physician, based on the overalltreatment regime of the patient.

A potential benefit of providing cross-treatment responsiveness to animplanted medical device is to assist a primary care physician inintegrating a plurality of simultaneous therapies.

An aspect of some embodiments of the current invention relates tomedical devices which are self-configuring in a device parameter domain,based on inputs provided in a patient performance domain. Optionally,the medical device comprises an implanted medical device; for example, apacemaker, implantable cardioverter defibrillator (ICD), cardiacresynchronization therapy device (CRT-D), left ventricular assist device(LVAD) neurostimulator and/or contractility modulation IPG (implantedpulse generator).

In some embodiments, the self-configuring of the medical device is basedon an automatically applied transformation of inputs derived frompatient performance domain observations into changes in theconfiguration of the medical device which affect technical parameters ofits operation. Such a technical parameter optionally comprises, forexample, a voltage, impedance, electrode characteristic, rate of change(slope/first derivative), rate of rate of change (slope of rate ofchange/second derivative), maximum rate, energy to be delivered, and/orthresholds defining events.

Herein, a group of such technical parameters, taken together, defines atechnical parameter domain; conversely, the parameters are said to bewithin a technical domain. An operating configuration for a devicecomprises a selection of settings for parameters within a technicaldomain.

In some embodiments, the transformation comprises direct manipulation ofa selected subset of parameters in the device parameter domain, whichare determined to correlate in their values to effects produced in thepatient performance domain. In some embodiments, the transformationcomprises selection of a device configuration option describing thesettings of a plurality of device parameters. The selection isoptionally of a predetermined device configuration, or of a deviceconfiguration arrived at by application of one or more rules associatingthe patient parameter domain to the device parameter domain, via datadescribing options for device configuration.

A potential advantage of the self-configuring is to allow anon-specialist medical practitioner, familiar with evaluation in thepatient performance domain, to perform adjustments to the medicaldevice. This is optionally without manipulation of or familiarity withthe low-level configuration details of the medical device. Potentially,this allows the device to be tuned to the conditions of an individualpatient, without constant involvement of specialist medical personnel,and/or in the course of routine primary medical care of the patient.

Features of certain rate-responsive cardiac pacemakers provide anexample of the complexity potentially accompanying implantable medicaldevice configuration.

Such cardiac pacemakers are configurable to recognize bodily motion andchange the heart rate accordingly. Suitably configured, this allows apatient to perform exercise that increases cardiac demand—and have thecardiac output increase to meet it, while remaining under suitablepacing control by the device.

A pacemaker with a rate responsive feature optionally uses deformationof a piezoelectric crystal to detect acceleration. Definition of howcontrol of how pacing (and thus, heart rate) should respond to anacceleration event optionally includes the definition of parameters fromthe following (non-exhaustive) list:

1. A minimal amplitude of acceleration marking possible event onset.

2. One or more event onset validation parameters, for example, a majorfrequency component, a minor frequency component, and/or a frequencymodulation criterion.

3. A duration of acceleration that confirms the event.

4. Parameters governing trend monitoring during confirmed events,defined for one or more classifications; for example as minimum percentrise in acceleration, and duration of trend sampling time.

5. Parameters defining response to a trend-classified event; forexample: latency to response, time slope of pacing rate increase,maximal heart rate, dependency of time slope on acceleration trend,and/or dependency of maximum heart rate on acceleration trend.

It should be noted that not only are many parameters described in theforegoing list, these parameters also potentially interact with oneanother. For example, if acceleration trend determination is adjusted tobecome more responsive, it may also become prone to noise; this mayrequire reduction in response time slope in order to reduce incidence ofspurious pacing increases. Management of this complexity generally isoutside the domain of a non-specialist.

Optionally, however, a primary physician can become familiar with thegeneral effects associated with rate-responsive cardiac pacemakers inthe patient domain (e.g., greater range of allowable exertion, tradedagainst possible triggering of events such as atrial fibrillation). Insome embodiments, this knowledge is sufficient to allow selection of theoperating configuration of a suitably prepared medical device.

Patient performance parameters optionally include any observation of apatient; for example, a test result (e.g., metabolite level, imagingdata, and/or monitoring data), a symptom, and/or another clinicalfinding. A patient performance parameter optionally comprisesmeasurement of a response to exercise, food consumption or fasting, druginjection, or another manipulation. Other examples of patientperformance parameters include, for example, exercise tolerance, pain,shortness of breath, dizziness, weight loss, and/or water retention.

An aspect of some embodiments of the current invention relates tomedical devices which are at least partially self-training fordetermination of a relationship between a device parameter domain and apatient performance domain. In some embodiments, a device operates toreceive sensed patient performance data, and determines a correlation ofthe data with a current and/or recent configuration of the device in adevice parameter domain. Optionally, configuration of the device inresponse to this correlation comprises adjustment of a configurationchange response to control inputs, so that a predictable relationshipbetween control input and patient performance is established,maintained, and/or restored.

Sensed patient data optionally comprise, for example, activity level(accelerometer-derived, for example), heart rate, electrocardiogram wavefrom, temperature, respiratory rate, blood metabolite level (forexample, glucose), or another sensed parameter.

It is to be understood the descriptions provided herein in terms ofdomains and/or spaces are not referring to literal volumes, nor tomathematical abstractions as such; rather, such descriptions are ways ofdescribing and/or conceptualizing certain realized features of someembodiments of the present invention.

It should also be noted that reference is also made herein to devicescomprising representations of more than one domain/space of any giventype.

For example, a device parameter domain is optionally defined by theranges of settings which can be adopted by particular control elements(registers, for example) of a medical device. Insofar as settings inthis domain are ordered with respect to one another (or otherwiseprovided with structural relationships), they are optionally alsoconsidered to define a device parameter space. In some embodiments, itis appropriate to consider a sub-domain of a whole device parameterdomain, and/or to consider the device as comprising settings whichdefine two separate device parameter domains.

A patient performance domain is optionally defined in the first instanceby one or more patient observables (which are observable to obtain anobservation result such as a test result, symptom, and/or anotherclinical finding). Insofar as different observation results arerelatable to each other, for example, according to an order, theyoptionally comprise a patient performance space. Preferably, observablesare affected by operation of the medical device. There is optionallymore than one patient performance domain to consider—for example, twoobservables may be equivalent in their relationship to the configurationof the device, or equivalent after a suitable transformation.

In some embodiments, an appropriately programmed medical device at leastpartially embodies a description of a patient performance domain,insofar as it is capable of receiving input closely derived from patientobservables, and then reconfiguring itself to produce substantiallypredictable effects on those same observables, and/or on other patientobservables. In some embodiments, this capability for reconfigurationrelies on a transformation (such as a mapping) that can be appliedbetween the patient performance domain, and the device parameter domain.

In some embodiments, moreover, it is useful to distinguish a controldomain (or space). This is the domain in which the medical devicereceives its inputs. Except as may be otherwise explicitly indicatedherein, “control domain” and/or “control space” are used with particularreference to inputs having a direct (or other simple) relationship tosome patient performance domain. There may be more than one such controlspace available.

In an example of what should be understood as a simple relationshipbetween a control space and a patient performance space: a control spacemay comprise discrete control states selectable by the pressing ofbuttons, for example, two buttons such as “+” and “−”, for movement of aselected control state up and down in an order of such states. States ofa corresponding patient performance domain as such, however, optionallyare not be themselves discrete, optionally comprise more or fewerobservables (axes, in some embodiments) than the control space exposes,and/or otherwise differ from strict one-to-one correspondence to thecontrol domain. However, even with such caveats in view, it will begenerally appreciated that a selection in control space may have a clearand direct correlate in patient performance space: for example, the “+”button optionally corresponds to an increase in both a treatment effectand a side-effect, and the “−” button to a decrease in both.Accordingly, the control domain/space and the patient performancedomain/space are sometimes referred to herein in combination ascomprising a patient performance space or domain.

Before explaining at least one embodiment of the invention in detail, itis to be understood that the invention is not necessarily limited in itsapplication to the details of construction and the arrangement of thecomponents and/or methods set forth in the following description and/orillustrated in the drawings. The invention is capable of otherembodiments or of being practiced or carried out in various ways.

Interactions between Patient, Different Care Providers, and ImplantedDevice

Reference is now made to FIG. 1A, which is a schematic block diagramrepresenting interactions among a patient 10, an implanted medicaldevice 40, a primary care physician and/or clinic 30, and an implantingphysician and/or clinic 20, according to some exemplary embodiments ofthe invention.

The double-headed arrows 42, 44, 46, 54, 56, 52 represent differentpairwise interactions between agents in relation to an implantablemedical device: a patient 10, a primary care physician (and/or clinicand staff) 30, a device implanting physician (and/or clinic and staff)20, and the implantable medical device 40 itself.

The expertise and personal patient knowledge of primary care physiciansis a valuable and efficient resource. Typically, however, directinteraction 42 between a primary care physician 30 and an implanteddevice 40 is rare or unavailable. The role of a primary care physicianin device 40 management is often relegated to indirect actions, forexample, initial referral to and occasional consultation with animplanting physician 20 along interaction route 52. Factors contributingto this limitation potentially include:

-   -   There is no direct control of the device 40 given to the primary        care physician 30;    -   Mastering the complexity of the device 40 is not within the        scope of the primary care physician's knowledge and/or duties;    -   Once the device 40 is implanted, a key aspect of the patient's        health becomes the domain of a specialist, and the primary care        physician 30 may substantially be excluded from this piece of        the clinical picture.

In some embodiments of the current invention, an implantable medicaldevice comprises features that potentially enhance the ability of aprimary care physician to participate in the ongoing management andmonitoring of the device, turning primary care-implantable deviceinteractions 42 into an important part of the patient's care. Potentialadvantages for increased association of a primary care physician 30 withan implanted medical device 40 of a patient include:

-   -   Increased communication with the patient, in frequency and/or        over time, to guide personalization of device operation;    -   Lower threshold of need and/or more frequent opportunities to        adjust device operation;    -   Adaptive integration of device operation with other medical        treatments; and/or    -   Use of device monitoring features (for example, sensor data        provided live and/or logged, and device status and/or activity        logs) to guide an overall patient treatment regimen, that        optionally includes one or more other devices and/or drug        treatments.

Reference is now made to FIG. 1B, which is a schematic flowchart of howa primary care physician (MD^(P)) interacts with an implantable medicaldevice, according to some exemplary embodiments of the invention.

At block 102, in some embodiments, MD^(P) determines that an implantedmedical device is of potential benefit to a patient, and makes areferral to an implanting physician accordingly. In this example, thedevice is an implanted pulse generating device (IPG) for the sake ofillustration; for example, a device for delivery of cardiaccontractility modulation (CCM), gastric contractility modulation (GCM);for deep brain, spinal, or other central nervous system stimulation;and/or peripheral nervous system stimulation. However, it is to beunderstood that in some embodiments, another type of implantable medicaldevice is the object of the method, for example, a ventricular assistdevice (VAD) or implantable cardioverter-defibrillator (ICD).

At block 104, in some embodiments, the device is implanted by animplanting physician (MD) and/or associated clinic and staff.

At block 106, in some embodiments, the MD' and/or associated clinic andstaff prepare a device for the situation of the individual patient. Fora typical device, preparation includes determining the relationshipbetween the operational parameters of the implantable device, and theireffects on the patient Implantable device parameters are potentiallycontrolled by up to several hundred different device settings.Optionally, a plurality of parameter sets is prepared to cover futuremedical and treatment eventualities. For example, treatment parametersare determined having greater or lesser therapeutic effects, differentbalances of therapeutic effect to side-effect, different assumptionsabout the therapeutic environment of the device (other ongoingtreatments), and/or different thresholds to prevent incorrect activationof the device.

At block 108, in some embodiments, the (MD^(P)) is linked to theimplanted device. Linkage of MD^(P) and device is optionally by one ormore of the following methods, or by another method:

-   -   The MD^(P) has, supplies, is given control over, and/or is        provided access to a device component (for example, a device        charger, or a data store containing device configuration data)        that is required for operation of a therapeutic function of the        implanted medical device.    -   The MD^(P) has a code (for example, a cryptographic key,        alphanumeric code), or another identifying token, comprising a        key to which the implanted medical device is programmed to allow        access for activating and/or modifying a function of the device        (for example, a monitoring function or a therapeutic function).

In the case of an identifying token, there are different options forcreating a token-to-device association. These include, for example, oneor more of the following:

-   -   The token is previously assigned to the MD^(P) (for example, by        a device manufacturer), provided by MD^(P) along with the        referral, and recognition of the token is programmed into the        implanted device by the MD^(I) as part of the implantation and        configuration procedure.    -   Recognition of the token is programmed into the implanted device        by the MD^(I), as part of the implantation and configuration        procedure. The token is provided by the MD^(I) to a patient to        give to his MD^(P) and/or provided directly to a referring        MD^(P).    -   The token is previously assigned to the MD^(P) (for example, by        a device manufacturer). The device recognizes the token as valid        upon first presentation (for example, when a patient first        visits the MD^(P) post-implantation). Optionally, primary care        functions of the implanted device are exclusively associated        with that token thereafter. The association is optionally        transferable and/or non-exclusive.    -   The device itself provides a token (cryptographic key, password,        or other information) upon correct interrogation by an MD^(P),        and thereafter access to the implanted device is allowed upon        presentation of the provided token.

Optionally, there is a plurality of access tokens, each associated withan implanted medical device, either individually or as a group.Optionally, each access token provides access to some or all of thedevice functionality intended for use by a primary care physician.Optionally, acceptance of an access token by the device is permanent ortemporary (for example, time or use limited). For example, a tokenproviding access to logging features of the device is permanent, a tokenproviding access to initiate a therapeutic regime is time limited (forexample, to help ensure that the device is not operated beyond the duedate of a designated periodic maintenance check), and/or a tokenproviding access to specialist consultation features of the device isuse limited (for example, for controlling access to device services suchas a post-implantation follow up with an implantable device specialist).

At block 110, in some embodiments, the MD^(P) manages device therapyadministration, corresponding to the interactions of interaction arrow42. Optionally, primary care device management occurs during regularcheckups, and/or other visits of a patient to a primary care provider.

In some embodiments, implanted device operations are packaged for theprimary care provider in terms of “doses”, and/or otherwise simplifiedrelative to the large number of programmable parameters that a devicenatively presents.

Optionally, medical device operation by a primary care physician ismodeled on a “prescription”-type model, wherein one or more aspects ofthe operation of the device are mapped to provider concepts that areconventionally used for pharmaceuticals. For example, with the increasedrange and/or availability of therapeutic functions in implantablemedical devices, there is a potential for devices to overlap in theirtreatment indications with pharmaceutical medicaments that areordinarily prescribed and/or monitored at the level of primary care.

In some embodiments, a treatment regime that is pre-prepared foravailability from an implanted medical device (a stimulus regime, forexample) is selected by a primary care physician to run for a certainperiod of time, a certain frequency, and/or with a certain strength ofstimulation or other measure of therapeutic effect intensity.

For example, a cardiac contractility modulation (CCM) device isconfigured to run for a certain number of hours per day.

Additionally or alternatively, settings of a device provide alternatives(optionally, gradated alternatives) between two or more states thatdifferentially affect patient performance parameters and/orside-effects. For example, stabilization of an organ function (such asheart rate, endocrine secretion rate, nerve activity level, and/orkidney efficiency) is balanced differently in two or more settingsagainst retaining the organ's ability to meet dynamic demands on it due,for example, to changing activity, health, and/or effects of othertreatments. A more stable setting potentially provides more healthsafety, such as a lowered risk of decompensation, while a more dynamicsetting potentially enables a more normal lifestyle.

Potentially, this kind of simplification makes it easier for a primarycare physician to evaluate the effects and benefits of an implantedmedical device in terms that can be more easily understood in relationto pharmaceutical medicaments.

Equipping a primary care physician with this perspective may help thephysician to accept, and even encourage, the use of an implantablemedical device as part of an overall therapeutic regimen for diseasetreatment and management.

In some embodiments of the invention, features of an implantable medicaldevice that tie it into operations performed and/or selected in thecontext of primary care also serve to support business and clinicalinfrastructure aspects of implantable medical devices. Such aspectsinclude, for example, sales and distribution, technical support, billingand insurance reimbursement, and medical training. It is to beunderstood that some of these aspects potentially behave synergisticallywith respect to features that tie a device to a primary care physician.For example, greater familiarity with a device and its effects(achieved, for example, at block 110 of FIG. 1B), potentially encouragesMD^(P) to make future referrals at block 102.

Understanding by MD^(P) that the patient will return with the optionsfor future treatment enhanced, rather than locked away in aninaccessible device, may also encourage referrals. The implantingphysician 20 and device supply chain also potentially benefit from widerfamiliarity with and acceptance of the device in the wider medicalcommunity. Where use of an implanted medical device is associated withdecreased costs at the point of treatment, and/or in the medical systemoverall, there are potential benefits for payers in reducing barriers todevice deployment.

Reference is now made to FIG. 1C, which schematically represents therelationship of healthcare and other services relative to a patient 10and a device 40, according to some exemplary embodiments of theinvention.

In some embodiments, tasks relating to an implanted medical device 40are shared among a plurality of healthcare and other service providers.In some embodiments, a coordinating service 70 mediates between theseproviders and the device 40.

A coordinating service 70 optionally comprises, for example, a computerserver and/or a call center. Optionally, a concern of the coordinatingservice 70 includes ensuring that the plurality of service providersthat can affect device operation do not provide conflicting operation ofthe device. Other optional functions of the coordinating service 70include collecting, storing, and/or distributing configuration and/orlog data about the device 40. In some embodiments, access to the device40 is directly or indirectly through the coordinating service.Optionally, the coordinating service 70 links directly to theimplantable medical device (optionally using a secure standardnetworking method such as wireless networking).

Optionally, controllers operate through this direct network link.Potentially this allows the coordinating service 70 to be fully aware ofall activities relating to the device. Additionally or alternatively,the coordinating service “introduces” a controller to a device, forexample by an exchange of tokens such as access keys. Optionalrelationships between coordinating service 70, device 40, and anotherservice include the following examples.

In some embodiments, an implanting service 20 introduces a device 40into a coordinating service 70. Optionally, the implanting service 20stores additional data about the device 40 on the coordinating service.For example, test and/or configuration data (optionally, alternativeconfiguration parameter data sets) are uploaded to the coordinatingservice.

In some embodiments, at least a portion of the range of configurationoptions which will be available to a primary care physician 30 isdetermined by the implanting service 20, and optionally made availablethrough the coordinating service.

In some embodiments, a primary care provider 30 interacts with acoordinating service 70 for one or more of gaining access to theimplanted device 40, accessing alternative parameter sets previouslyconfigured for used with the device 40, uploading log data from thedevice 40, and/or communicating with other services about the device(for example, communicating with services of the implanter 20, themanufacturer service 50, and/or a consulting service 80). Optionally, aprimary care provider interacts with a coordinating service 70 as partof an initial referral of a patient 10. Optionally, this associates theprimary care provider 30 with the patient 10 and device 40, for purposessuch as assigning the primary care provider for care management duringlater treatment with the device 40.

In some embodiments, other primary care providers 33 potentiallyinteract with the coordinating service 70 and device 40. For example, ifa patient is away from the usual primary care provider 30, thecoordinating service allows some subset of interactions between deviceand other primary care provider 33. Optionally, the main primary careprovider 30 is later able to be updated about such interactions via thecoordinating service 30. In some embodiments, the primary care provider30 is contacted via the coordinating service 70.

In some embodiments, other services are brought into the system over thelife-cycle of the implanted medical device 40. For example, contact witha medical consultant 80 such as a device specialist is made through thecoordinating service 70. Similarly, access to a follow-up service 60(optionally the device implanter) is optionally arranged through acoordinating service 70. In some embodiments, a manufacturer service 50is brought into the system, for example during operations by theimplanting service 20, and/or for servicing of the device during thedevice life-cycle.

It is to be understood that each of these services optionally interactswith the device away from a designated coordinating service 70, and/orthat there is more than one coordinating service 70, each of whichcoordinates a different aspect of interactions over the device 40.However, it is a potential advantage to have a single coordinatingservice which centralizes interactions with the device 70, for exampleto help ensure consistent performance tracking and device management.

Reference is now made to FIG. 1D, which schematically represents therelationship of controllers, sensors, and other components of a systemsupporting management of an implantable medical device 40, according tosome exemplary embodiments of the invention.

In some embodiments, there are a plurality of different components of amedical device system which interact (directly, or indirectly, forexample, through a coordinating service 70) with the implanted device 40itself.

Some components comprise controllers. For example, a device specialistis optionally provided with a full programming controller 156, to allowprogramming of every available aspect of a device's operation. A primarycare provider optionally uses a primary care controller 152. A primarycare controller optionally provides functionality which is targeted atthe tasks of primary care—for example, by presenting a reduced number ofconfiguration options, and/or by presenting configuration options interms of more basic clinical concepts (for example, patient performanceand/or treatment regime or “dose”). A patient is optionally providedwith a mode selector 154, for example, to allow control that adjustsdevice operation according to the patient's daily routine. It is to beunderstood that the physical partitioning of a controller's functions isoptionally divided among device 40, coordinating service 70, and one ormore additional controllers. For example, a “controller” optionally isdesignated by possession of a key providing access to an interface ofthe coordinating service 70, which is what direction accesses theimplanted device 40 itself.

Some components comprise sensors. Device sensors 160 are optionally partof the device itself (provided for logging and/or to modulate devicefunction).

Additionally or alternatively, an implanted device is configured tointeract with one or more external sensors 166. These are optionallysensors of other implanted devices.

Optionally external sensing comprises information obtained from a publicor semi-public source, for example, weather data, emergency servicesstatus information, or information available from a social media datasource.

Some components comprise other data. In some embodiments, a parameterdata store 158 is provided which stores one or more (typically, aplurality or multiplicity) valid configurations of an implanted medicaldevice 40. Optionally, the parameter data store is part of the implanteddevice 40 itself. However, the parameter store is optionally part of acontroller, part of and/or accessed through a coordinating service 70,and/or is a separate component. In some embodiments, a logging datastore 162 is provided. The logging data store optionally stores datafrom the device, for example, telemetry recording operation of thedevice itself, and/or sensor data.

Device Parameter Changing Scenarios and Operations

Reference is now made to FIG. 2A, which is a schematic flowchartrepresenting different domains for implantable medical devicemanagement, according to some exemplary embodiments of the invention.

In some embodiments, there are at least three domains within which animplanted medical device is operated: a technical parameter domain 21, apatient parameter domain 31, and a daily life domain 11. Roughly, thesecorrespond to operations performed by a device implanter 20 or anotherdevice specialist, a primary care provider 30, and the patient 10 him-or herself.

In some embodiments, the technical parameter domain 21 comprises deviceoperations where a deep level of device adjustment is potentiallyperformed. For example, these adjustments are made together withimplanting, as part of low-level post-implantation configuration, and/oras part of major servicing operations during the later life-cycle of theimplanted device.

In some embodiments, patient parameter domain 31 includes management ofthe device in connection with primary care by a physician or clinic.Optionally, the adjustments are made at the level of managing patientparameters such as therapeutic effect and/or side-effect strength. Insome embodiments, this management comprises selecting a predefinedparameter set which is associated with a desired clinical effect (orchange in clinical effects). Management optionally comprisesdeliberately introduced variations in device operation to try tooptimize performance, and/or changes made in consultation between aprimary care provider and a device specialist.

In some embodiments, daily life parameter domain 11 comprises functionssuch as functional monitoring and/or device-self checks only.Optionally, a minimal control is provided to the patient, for example,to control activation of the device with respect to patient activities(for example, to activate GCM before eating).

Optionally, a patient is allowed to select from among two or morereasonable parameter sets, for example, in order to determine whichparameter set gives results which work best with the daily routine ofthe patient.

Reference is now made to FIG. 2B, which is a schematic flowchartrepresenting modes and operations of an implantable medical device, withrespect to an implanting physician and/or clinic 20, a primary carephysician and/or clinic 20, and a patient 10, according to someexemplary embodiments of the invention.

In FIG. 2B, blocks 202-220 indicating activities of implanted medicaldevice management are shown relative to blocks indicating the patient10, primary care provider (primary care physician, staff, clinic, orother organization 30), and implant provider (implanting physician,staff, clinic, or other organization 20) in whose domain the activitiesoccur.

The flowchart begins after implantation of the device. At block 202, insome embodiments, the device is checked and programmed by the implantprovider.

Details of the programming depend on the type and model of the medicalimplant device provided. Examples now given relates to a rate responsivecardiac pacemaker, but it is to be understood that these examples areindicative only, and that some embodiments of the invention coverprogramming of other devices, changed as necessary for the functions ofthe device. The descriptions may be understood to include a portion ofthe total range of parameters that an implanted medical device canpresent for programming, as an indication of the scope of parametersthat are dealt with in some embodiments.

In some embodiments, a rate responsive cardiac pacemaker is programmedto change the heart rate based on detected motion (acceleration, forexample) of the body. For example, a piezoelectric crystal functionallyconnected to the pacemaker (optionally, within it) detects acceleration.Parameters that optionally define an increased heart rate response bythe pacemaker to the detected acceleration include, for example:

-   -   A minimal amplitude of acceleration that denotes an acceleration        event.    -   Parameters for sub-algorithms that validate the acceleration        event, optionally including but not limited to: major frequency        component, minor frequency component, and/or frequency        modulation.    -   The acceleration event durations that define each case for which        a different device response is available.    -   The trend of the acceleration signal as it relates to device        response; for example: percentage rate of rise of the        acceleration signal, percentage change within a rolling sampling        window and/or the duration of that window.    -   Parameters governing the response to acceleration of the        pacemaker for each distinguished acceleration event case, for        example: latency from acceleration case to response, rate of        pacing increase, maximal heart rate, rate of pacing increase as        a function of event features (for example, acceleration), and/or        maximal heart rate as a function of event features.

These samples of device parameter complexity indicate the complexity ofthe whole device, as well as indicating the potential interdependence ofparameters to be configured.

In some embodiments, parameters are set up based on testing of theimplanted device and/or the patient, for example, within the clinicalfacilities of the implant provider. Optionally, these data are used bythe implant provider to generate a default configuration (deviceparameter set) for the device. In some embodiments, more than one deviceparameter set is generated for the device, for example, based onmeasurements and calibrations during different activity levels of thepatient in testing, based on experience with other patients, based onexpected potential disease states of the patient as the disease changesover time, and/or based on known or potential effects of auxiliarymedical treatments.

Although patient performance is optionally gathered during this setupstage, there are practical limits on how much data can be gathered, andfurthermore, predictions of the future evolution of patient performanceand/or disease state are only estimates. Even where a suitable parameterset is available for a change in conditions, the device may not be ableto automatically determine which parameter set that is. For these and/orother reasons as described herein, programming and parameter setselection is optionally modified throughout the use of the implantedmedical device.

At block 204, in some embodiments, the device is optionally set into a“safe mode”. The safe mode is an option whereby the device is set sothat critical life-supporting functions work, while other treatmentfunctions are inactive, and/or persist only for a limited period oftime. This is a potential benefit to ensure that a patient is notsubjected to a long period of unsupervised treatment after finishinginitial device configuration. After block 204, the patient and theimplanted medical device leave the care of the implant provider 20.

At block 206, in some embodiments, an expiration check is made on thecurrent operating mode of the device (which may be the “safe” mode, oranother mode). If the safe mode duration expires without attention froman authorized medical professional, the device optionally drops into amaximally inactive mode at block 208. Optionally, the safe mode operatesfor, for example, a week, two weeks, a month, three months, or anotherlonger, shorter, or intermediate time before the inactive mode is set.

At block 210, in some embodiments, the patient enters the care of aprimary care provider 30. In some embodiments, the primary care providerputs the device into a “follow-up” mode. The features of a follow-upmode can vary by device, and optionally include:

-   -   Activation of therapeutic activities.    -   Activation of device monitoring and/or recording.    -   Charging of the device.    -   Linkage of a primary care provider to a device (for example as        described in relation to block 108).

In some embodiments, linkage of a primary care physician to a device isexclusive—that is, only one primary care provider can manage any givendevice. It is a potential advantage to exclusively link a primary carephysician to a device, for example, to prevent accidental interferenceamong changes made by other care providers. Nevertheless, in someembodiments, linkage of a primary care provider to a device does notpreclude full access to the device by a device implanter or other devicespecialist.

At block 212, in some embodiments, device checks and/or updates areperformed by a primary care provider. Optionally, the device is checkedby a primary care provider to ensure that the device is working withinexpected parameters.

Optionally the performance states of the patient and the device arechecked and/or considered to determine if the current set of deviceoperating parameters should be altered. Examples of reasons to changeparameter sets include a change in patient performance, a complaint byor observation of the patient, a change in the activity of the patient,and/or a change in parallel treatments provided to a patient.

In some embodiments, device configuration changes are made based oninformation that is unavailable or difficult to obtain at the time ofinitial configuration. For example, determination of a preferred devicesetting is dependent on patient choice—but the patient lacks experienceto decide what to choose until leaving the initial care of the implantprovider. Additionally or alternatively, the preferred setting isdependent on the current routine or lifestyle of the patient, andsubject to change according to the patient's activities. Additionally oralternatively, the preferred setting is chosen according to medicalperformance data obtained over an extended period of time (months oryears, for example), and/or a medical state of the patient that itselfchanges over time (for example, as patient well-being increases ordeteriorates).

In some embodiments, a change in parameters comprises switching thedevice to use a parameter set that was determined (and optionallyprogrammed into the device) at the time of initial device implantation,or predetermined at a later time.

In some embodiments, new parameter sets are provided as a range ofgraded (or otherwise ordered in terms of values and/or effect) changesto one or more parameters of the device. Optionally, the decision tochange from one setting to the next comprises moving in one direction orthe other in the parameter set order.

Optionally, details of the device parameter space is transparent to theprimary care physician, and the ordering is in another parameter space,for example, a measure of patient performance, side-effect occurrence,“dose” strength, or another description of parameter state.

In some embodiments, a primary care provider guides and/or monitors“A-B” type optimizations of device parameters. For example, a primarycare provider selects two or more parameter sets (from among a pluralitypredefined, for example, at the time of device implantation), andswitches between them during different patient visits (or according toanother schedule), gives the patient the freedom to choose one or theother parameter set, or otherwise arranges for real-world comparativetesting. Optionally, choice is randomized, but recorded by the devicefor later review, allowing a blind or double-blind study at the level ofan individual patient's treatment. Optionally, for example, after theresults of several weeks or months of experience with the device areobtained, an implant specialist is consulted (for example, together withthe primary care provider), presenting this data for further evaluation.Optionally, the device specialist uses the results to generate newparameter sets suitable for evaluation by the patient and the primarycare physician.

Optionally, the primary care physician works with the patient todetermine what optimizations are most desired, and the device specialistarranges new parameter sets for trial accordingly.

From block 214, in some embodiments, if the device is functioningproperly and does not need reprogramming, the flowchart continues withblock 216; otherwise flow optionally returns to block 202 so that thedevice can be serviced and/or reprogrammed.

In some embodiments, at least some types of interactions between animplanted device and the device specialist 20 are optionally mediated bythe primary care provider 30.

For example, conferencing (for example, teleconferencing) or othercommunication is arranged between primary care provider, devicespecialist, and optionally the patient. In some embodiments, animplanted device and/or a support system for the device comprisesfacilities for remote transmission of telemetry and/or remote updatingof device parameters. The primary care physician potentially plays acentral role in facilitating the interaction between device specialist,patient, and device; translating the global clinical situation of thepatient into subjects that the device specialist can address, andverifying, conversely, that the device specialist's solutions areconsistent with the patient's clinical situation.

Blocks 216, 218, and 220 optionally occur in the domain of the patient'sdaily life with the implanted medical device.

At block 216, in some embodiments, device self-checks periodicallyoccur, including verification of the status and operation of the deviceitself, and optionally verification that any clinical situation it hasbeen “told” about during device configuration remains within anticipatedparameters. Self-checks optionally occur continuously or with highfrequency (with every pulse, for example), hourly, daily, weekly,monthly, or at another longer, shorter, or intermediate interval.Optionally, different self-checks occur with different frequencies.

In some embodiments, a patient is optionally provided with a certainamount of control over operation and/or settings of the device, forexample as described in relation to block 212. In some embodiments, thepatient optionally selects from among one or more available deviceparameter sets that have been previously cleared by the primaryphysician for personalized testing. In some embodiments, parameter setsare selected by the patient as part of daily use of the device—forexample, to activate, deactivate, or modulate stimulation or otherdevice activity according to the activities of the patient. Optionally,device logging records these setting changes and/or their results,providing an objective record of implanted device function that aprimary physician can refer to in discussions with the patient on futurevisits.

At block 218, in some embodiments, if some sufficiently serious problemwith device operation is found or suspected based on device checks, thepatient returns to the primary care physician at block 212, so that theproblem can be solved by the primary care physician and/or a devicespecialist if referral or consultation is found appropriate.

Otherwise, flow continues at block 220, in some embodiments. Optionally,the device determines if it is time for a scheduled check, for example,due to the expiration, completion, and/or other termination of atreatment regime. A treatment regime terminates, for example, after acertain number of uses, and/or due to achievement of a predetermined endpoint. Optionally, reaching the end point is automatically sensed by thedevice. For CCM, for example, the end point is reached according to oneor more criteria of sensed acceleration, contractility, and/or heartrate. Additionally or alternatively, another criterion is set, forexample, based on sensed levels of a secretion and/or blood glucose(potentially relevant, for example, to GCM in diabetics). Optionally,this results in an alert to the patient. Optionally, for example if thedevice has not interacted with a primary care physician recently enoughto ensure continued safe operation of the device, the flowchart returnsto block 206, and the device optionally enters an at least partiallyinactive mode at block 208 until reactivated by a primary carephysician. If there is no issue requiring professional medicalattention, the diagram cycles back to block 216.

Reference is now made to FIG. 3, which is a schematic diagramrepresenting interactions among a primary care physician and/or clinic30, a patient 10, a first implanted medical device 40, one or moreadditional devices 40A, and medicaments 40B, according to some exemplaryembodiments of the invention.

In some embodiments, a primary care physician 30 who is overseeingadministration to a patient 10 of auxiliary treatment(s), for example,other devices 40A, and/or medicaments 40B in parallel with treatmentdelivered by implanted medical device 40 provides the device viainteractions 42 (for example, programming, data entry, and/or optionselection) with information about the auxiliary treatment(s) 40A, 40B.Optionally, the parameters of device 40 are altered in compensation.This is a potential advantage when there are potential interactionsamong the effects 46, 46B, 46A that implanted medical device 40, otherdevices 40A, and/or medicaments 40B have on the patient 10. Primary carephysician 30 is potentially assisted in the overall goal of patienthealth management by this; for example, more options are potentiallyavailable for prescriptions 42B, 42A of medicaments 40B and/ormanagement of other devices 42A, when at least one device 40 is capableof reactive changes in response to other treatments.

As an example of a situation where treatment interactions potentiallyarise: a patient being treated for congestive heart failure is providedwith both beta blocker medicament 40B and an implanted medical device 40for administration of cardiac contractility modulation (CCM). CCM is atreatment modality (used, for example, in the treatment of heartfailure) in which electrical stimulation is applied to cardiac muscleduring its absolute refractory period. Potentially, this enhances theheart's natural contractions. Potentially, CCM at least partiallyreverses disease-related changes to heart structure.

Optionally, the receipt and/or effect of beta blockers by the patientchanges over time, for example due to changes in the prescription,changes in physiological response to a prescription, and/or changes orinconsistency in patient compliance.

Potentially, these changes affect the optimal treatment parameters forCCM—for example, preferred stimulus strengths and/or timings, expectedpatient performance ranges, and/or threshold values.

In some embodiments, an input from a primary care physician to a CCMtreatment device (or another device 40 according to an embodiment of thecurrent invention) comprises a description of auxiliary treatments 40B,40A. For example, the input conveys details of:

-   -   A prescription (for example, of a drug 40B or other device 40A,        of dose, frequency, and/or another prescription parameter);    -   A patient's observed physiological responsiveness and/or        compliance; and/or    -   Other information about the historical, current, and/or        predicted course of the auxiliary treatment.

Optionally, the device is configured to operate according to deviceparameters that are modified based on this information. Optionally, thisconfiguration is without directly providing information about auxiliarytreatments to implanted device 40.

In some embodiments, changes in operation include activation of devicefeatures specific to operation in concert with an auxiliary therapy. Forexample, an implanted medical device for a heart optionally monitors theheart rate, and based on this infers whether a beta blocker prescriptionthat it has been informed of is currently in effect or not. Thispotentially allows the device to dynamically change operation based onthe most likely medical current physiological state of a patient.

Optionally, sensing that the device provides (for example, in order todirect its own functioning), acts as monitoring for the effects ofauxiliary treatments.

Device Access Keys, Usage, and/or Management

Reference is now made to FIG. 4, which schematically represents therelationship of different access key types to an implantable medicaldevice 40 and/or a coordinating service 70, according to some exemplaryembodiments of the invention.

In some embodiments, any service which interacts with a device (forexample, one of the services described in relation to FIG. 1C, oranother service such as an insurer, HMO, or other payer service) isoptionally given access through a key. A key unlocks (or adds) one ormore device functions, selected according to the configuration of thedevice and/or the key. The key is, for example, a number, alphanumericstring, or physical device. Validation of the key is optionally throughthe device 40 itself, through a controller configured to interface withthe device, and/or through a coordinating service 70. FIG. 4 shows avariety of different keys according to their source and/or type, inrelation to a device 40 and/or a coordinating service 70. It is to beunderstood that a plurality of keys optionally operate together to grantaccess to a device or device function. For example, a key that grantsaccess to a particular device optionally operates together with a keythat unlocks a particular therapeutic paradigm. This is a potentialadvantage to allow, for example, purchasing of services on an openmarket, while still enforcing exclusive access control over individualdevices.

In some embodiments, a key 402 is provided by a manufacturer to aservice provider, or a distributor key 414 is provided to a serviceprovider.

Optionally, the key is for a specific individual device 40. Optionally,the key grants more general access: for example, to a particular devicemodel, or for a particular range of serial numbers within the model.This access model is potentially appropriate, for example, as part of amanufacturer's certification and/or authorization of a third partyservice provider. In some embodiments, a distributor distributes devicesand one or more distributor keys 414 separately. For example, keys whichactivate a therapy regime of a device 40 are distributed separately fromthe device itself.

In some embodiments, a key 404 is provided by an implanter or otherdevice specialist to another service provider; for example, to a primarycare physician. This is of potential benefit, for example, to create anauthenticated link among service providers who will need to worktogether over the lifetime of a device 40, e.g., the implanted device.

In some embodiments, a key 406 is self-provided. This allows, forexample, an authorized primary care provider to “sign in” to a deviceworn by a patient entering his or her clinic. Additionally oralternatively, a self-provided key is placed on a device by someoneelse. For example, a referring physician includes a key with thereferral, and the implanter and/or device configurer activates theimplanted device to recognize that key. Additionally or alternatively, akey 410 is provided by a device, for example, upon receiving a queryrequesting one. Optionally, exclusive access to a device is enforce, forexample, by only issuing one such key, and/or by issuing adevice-specific key only upon presentation of a key credential whichallows general permission to access such a device.

In some embodiments, a key 408 is a component needed for an aspect ofdevice operation. The source is optionally dependent on the aspect. Forexample, a manufacturer or distributor distributes keys which comprise apower supply for an implanted medical device, and possession of such apower supply is controlled so that it is a form of access device whichallows enabling of one or more functions of the device. Additionally oralternatively, configuration data that directly enable a particularfunction of a device 40 are generated by a device implanter and/orconfigurer, but not put on the device 40 itself. Then the configurationdata can only be used to enable functionality by another serviceprovider who receives that data.

In some embodiments, a key 412 is provided by a payer, for example, aninsurer or HMO. This is a potential advantage, for example, to allowmarketing and sales effort by a manufacturer or distributor to beconcentrated at the level of a payer organization. The payer optionallypurchases keys in bulk, for example, keys which enable a therapyprovided by the device, which authenticate payment for a consultation orfollow-up service, or which simply serve as an identifier of a serviceprovider for the payer.

Components of an Implantable Medical Device System

Reference is now made to FIG. 5, which schematically representsrelationship among components of an implantable medical device system,from both the perspective of functional modules 505, and from theperspective of system components 500 implementing the functional modules505, according to some exemplary embodiments of the invention.

In some embodiments, the main components 500 of an implantable medicaldevice system comprise the implanted device 40 itself, one or morecontrollers and/or access devices 501, and optionally a coordinatingservice 70.

In some embodiments, the controllers and/or access devices 501 compriseone or more of the devices described, for example, in relation to FIG.1D.

In some embodiments, the coordinating service 70 comprises acomputerized server and/or call center, for example as described inrelation to the coordinating services of FIGS. 1C-1D, and 4.

In some embodiments of the invention, one or more of the functionalmodules 505 are implemented, each by one or more of the main components500.

Particular examples include:

Permissions module 502 optionally determines which device functions canbe accessed and/or modified in any given circumstances. Permissionsmodule 502 is optionally implemented at least in part by any one or moreof controller 501, coordinating service 70, and device 40. For example,access by a controller 501 to any of the functions of a device 40 uponregistration, confirmation, and/or approval by a coordinating service70. Additionally or alternatively, the device 40 and controller 501interact directly to determine access permissions, the coordinatingservice unlocks the device so that the controller can function, and/oranother combination of interactions is used to determine accesspermissions.

Parameter data store 504 optionally stores one or more parameter setswhich determine how an implanted device 40 functions. The parameter setsare optionally stored on the device 40, in a controller 501, and/orprovided by a coordinating service 70 (for example, received from adownload server). In some embodiments, the parameter data store isinitially configured by a device implanter or other specialist aroundthe time that the device is first implanted. Optionally, the parameterdata store 504 is updated during servicing, and/or by or in consultationwith a device specialist, for example, in response to the requirementsand/or clinical status of the patient.

Logging module 506 optionally records and/or makes available sensor dataand/or device performance data. In some embodiments, an implanted device40 comprises one or more sensors which optionally are used during normaldevice performance (for example, to synchronize the device to thephysiology of the patient), device configuration, device diagnostics, orfor another reason related to the function of the implanted medicaldevice 40. In some embodiments, log access is directly by a readoutthrough a controller 501, and/or mediated by a coordinating service. Forexample, a controller 501 mediates upload of log data read out from adevice 40 to a server of the coordinating service 70, which optionallydistributes the log data to medical care providers such as implanters,specialists, and/or primary care physicians, as needed.

Low-level programming module 508, in some embodiments, is used fordetailed device parameter configuration. In some embodiments, a specialcontroller (for example, programming controller 156) accesses the devicefor programming

Optionally, parameters are mirrored on a server of the coordinatingservice 70.

Additionally or alternatively, parameters are obtained from thecoordinating service 70, optionally through use of a controller 501, orotherwise after presentation of a key which is associated with thecorrect permissions.

Prescription manager module 510 optionally controls aspects of theoperation of implanted medical device 40 from the perspective oftreatment. Any or all of the system components optionally implement atleast a portion of prescription manager 510. For example, a treatmentplan is purchased from and/or with the verification of a coordinatingservice 70. Optionally, a prescription or permission token from thecoordinating service 70 unlocks the ability of a controller 501 toactivate a treatment plan on a device 40. Additionally or alternatively,the controller 501 transmits an unlocking token to a device 40 todirectly unlock a treatment plan.

It is to be understood that the preceding descriptions of systemarchitecture, including the division of modules 505 among systemcomponents 500, and specifics of their interactions, are non-limitingexamples indicative of how the functions of modules 505 are optionallyimplemented in an implanted medical device system.

Lifecycle of an Implantable Medical Device

Reference is now made to FIG. 6, which is a schematic flowchart of apatient moving through the life-cycle of an implantable medical device,according to some exemplary embodiments of the invention.

At block 602, in some embodiments, a patient optionally receives areferral from a primary care provider. Optionally, an arrangement ismade at this time to associate the primary care provider with theimplant and/or implantation process. For example, the patient is given akey identifier to bring to the device implanter.

At block 604, in some embodiments, the patient receives an implant.

At block 606, in some embodiments, the implant is configured.Optionally, the implant is configured by the device implanter, oranother implant specialist. In some embodiments, configuration of theimplant includes configuration of facilities (such as alternative deviceparameter sets, accessible ranges of parameter values, and/or otherfunctionalities) which will later be used by a primary care providersuch as a physician or clinic.

At block 608, in some embodiments, the patient is in a pre-treatmentphase of implant wearing. Optionally, a device does not become fullyactive (for example, for the administration of an elective treatmentsuch as CCM or GCM), until it is registered with or otherwise “unlocked”by a primary care provider.

At block 610, in some embodiments, the patient enters primary care underthe supervision of a primary care provider. Optionally, this comprisesunlocking access to the implanted medical device with a key possessed orobtained by the primary care provider. Optionally, the primary careprovider is the same provider who gave the initial referral at block602.

At block 612, in some embodiments, the device optionally undergoesupdates, reconfigurations, and/or servicing. Optionally, a primary careprovider acts as a gatekeeper to such changes. For example, the primarycare provider arranges a consultation with a device specialist(optionally a remote consultation), arranges a data connection toprovide log information to a device specialist, updates the devicespecialist on patient history and/or care requirements, or otherwiseparticipates in device maintenance.

Patient, Device, and Medical Caregivers

Management of Device Configuration

Reference is now made to FIG. 7A, which is a schematic diagram of animplantable medical device 40 which is selectably configured to producetherapeutic effects via a treatment modality 44A over one or morephysiological parameters; optionally based on patient performance sensedby a sensing modality 45, according to some embodiments of the presentdisclosure.

In some embodiments of the invention, an implanted medical device 40 isconfigured to produce a therapeutic effect (for example, a form ofphysiological control) via a treatment modality 44A. The treatmentmodality comprises, for example, an electrical stimulator, a magneticstimulator, supply of a pharmacologically substance, or anothertreatment modality appropriate to a targeted function of the implantedmedical device. In some embodiments, device 40 is a device forelectrically modulating heartbeat activity, such as a pacemaker.

As implanted medical devices grow in sophistication, deviceconfiguration comprises determining settings for an increasing number ofdevice parameters.

In some embodiments, an operating configuration 42C comprises at least10, 30, 50, 100, 150 or more configurable parameters in the technicaldomain which control how a device operates. In some embodiments, theparameters govern how a treatment modality 44A is activated. Forexample, parameters of an electrical stimulation pulse train optionallyinclude parameters governing pulse length, duty cycle, pulse number,pulse shape, pulse-train shape (ramping frequency, for example), and/orother parameters which affect how treatment is delivered.

In some embodiments, the operating configuration 42C includes technicaldomain parameters governing treatment modality 44A; optionally based oninputs from a sensing modality 45. For example, sensing modality 45optionally comprises an electrode configured to sense autonomic nervoussystem inputs to the heart, based on which a heart pacing treatmentmodality 44A induces and/or allows changing of a current heartbeat rateand/or a current heartbeat range.

In some embodiments, operating configuration 42C is selected from amongoptions described by device configuration option data 41. Optionally,device configuration option data 41 comprise a selection of discreteconfiguration options available, and/or descriptions which specify oneor more ranges which can be adopted by one or more variable parameters.Optionally, range specifications include constraints specified withrespect to other variable parameters.

Despite the flexibility in device operation that the use of largenumbers of parameters potentially provides, selectable configuration ontop of this provides a potential advantage for adapting toindividualized and/or dynamic performance requirements for delivery oftreatment.

In some embodiments, selection of an operating configuration 42C iscontrolled via a configuration selector 43. In some embodiments,configuration selector 43 operates to select an operating configuration42C from device configuration option data 41 based on measurementsand/or observations of states in a patient performance domain. Forpurposes of explanation, the patient performance domain isconceptualized herein as a patient performance “parameter space”,wherein an abstractly conceived parameter space is defined by one ormore parameter-associated axes or dimensions, along or through whichordered parameter settings are defined.

It is a feature of some embodiments of the invention that a parameter inparameter space is evaluated at least according to a targeted directionof change.

Optionally, the performance parameter space is based on one or morequantified physiological parameters, such as the results ofphysiological testing. In some embodiments, there is furtherdistinguished a control domain (explained in terms of a “control space”)which is mapped to effects in the patient performance to domain, butwith a different definition of axis direction and/or dimensionality. Forexample, a one-dimensional control space optionally selects controlconfigurations which span a two-dimensional patient performance space,which in turn spans a higher-dimensional device parameter space, as willnow be further explained, and also as explained, for example, inrelation to FIGS. 8A-8G.

Configuration selector 43 optionally interfaces with controls forswitching incrementally among operating configurations 42C; for example,switching one step in parameter space per press of a button. Preferably,the physical configuration controls are not part of the implantedportion of the device, but rather are provided as part of an externalcontrol interface 43A that communicates to the operating (e.g.,implanted) portion of the device via a port, wireless communicationinterface (e.g., a radio link), or other communication link. It is to beunderstood that the interface optionally comprises any suitablearrangement of interface elements, physical or graphical, and activatedby closing of contacts, control of a cursor, activation of a touchscreen, or otherwise.

In some embodiments, device configuration option data 41 are provided aspart of the configuration interface 43A (either additionally to orinstead of within an implantable portion of the device 40 itself). Theninterface 43A optionally acts substantially as a programmer for thedevice, except that only a limited portion of the device configurationoption data are sent to and stored on the device 40 itself at any giventime.

Optionally, a pair of controls is configured for up/down selection,e.g., “+” and “−” buttons with opposing effects. Optionally, more thanone such pair of controls is provided, for example, to allow separatecontrol of the selection of operating configuration 42C with respect totwo or more at least partially independent treatment and/or sideeffects. Optionally, controlling of operating configuration 42C byconfiguration selector 43 comprises another form of selection, forexample, selection by entry of one or more values, which index into orotherwise select from among the options defined by the deviceconfiguration option data 41. In some embodiments, configurationinterface 43A provides at least one default reset command, allowing, forexample, a rapid return to a last-known-good configuration, aconfiguration which is targeted for maximum safety (potentially at theexpense of causing additional effects which are unsuitable for dailyuse), and/or rapid return to another configuration.

In some embodiments, the device configuration option data areestablished, for example, near the time of implantation, by a specialistclinic and/or physician 20.

The specialist clinic comprises the special expertise needed to defineoperation of the implanted medical device in terms of device operationparameters specified within the device parameter domain (optionally alsoassociated with a device parameter space, as described, for example, inrelation to FIGS. 8A-8G).

The device parameters directly specify low-level device functionality.

Optionally, the relationship between the device parameter domain and thepatient performance domain can be as straightforward as the adjustmentof a single parameter in the device parameter domain, mapped to a singleparameter in the patient performance domain. Optionally, however, anynumber of patient performance parameters is mapped onto any number ofdevice parameters.

For example, a maximum heart rate allowed by a heart pacing device isoptionally mapped onto a patient performance domain comprising a measureof the patient's exercise tolerance. Control of the device by a primarycare provider then optionally comprises providing the device with acommand corresponding to “increase exercise tolerance”, leading to aresult of an increased maximum heart rate.

In a somewhat more complicated case, there are optionally other deviceparameter adjustments applied to compensate for secondary effects of thechange in exercise tolerance. For example, parameters related to thesensing of a triggered event such as atrial fibrillation are optionallyrelaxed to reduce the incidence of false positives. In compensation,there may be further changes to parameter settings; for example, moreaggressive ramp-up to actions taken by the device when atrialfibrillation is clearly detected. Potentially, any or all of theseadjustments occur without the primary care provider needing to be awareof their details.

In some embodiments, operation of the configuration selector 43, and inparticular, ordinary operation for selection of an operatingconfiguration 42C based on evaluation occurring in the patientperformance domain, is by a primary care physician 30, and/or anothernon-specialist health care provider, after low-level programming hasbeen separately provided. Herein, device operating configurations 42Cand device configuration option data 41 are sometimes herein referred toas being specified in device parameter space, and/or as comprisingspecifications of device parameters. Herein, specification of a settingfor configuration selector 43 is also referred to, for some embodiments,as comprising specification in patient performance space. Therelationship between device parameter space and patient performancespace is also described, for example, in relation to FIGS. 8A-8E herein.

Reference is now made to FIG. 7B, which is a schematic diagram of asystem for configuring the device configuration option data 41 of animplanted medical device 40, according to some exemplary embodiments ofthe present disclosure.

In some embodiments, device configuration option data 41 are programmedinto an implanted medical device 40 by a device programmer 63,optionally by operation of an associated user interface for programmingthe device. In some embodiments (for example, where some or all ofdevice configuration option data 41 resides with a configurationinterface 43A before being selected from and send to a device 42C),device programmer 63 optionally passes the device configuration optiondata 41 to configuration interface 43A, which in turn provided it todevice 40.

Optionally, device programmer 63 is itself part of the configurationinterface 43A. Physical separation of storage of the deviceconfiguration option data 41 from the implanted portions of the device40 provides the potential advantage of decoupling activities such asupdates and other servicing from requiring the physical presence of thepatient. Optionally, it can also help ensure and/or verify thatconfiguration changes are provided only at well-defined times such aswhen interface 43A and device 40 are in communication. Storage of deviceconfiguration option data 41 on the implantable portion of the device 40provides a potential advantage, for example, insofar as theconfiguration data are available for automated self-checks. Closerphysical association to the patient also ensures presence and/oridentity of the configuration data, which is a potential advantage, forexample, in an emergency condition.

Optionally, device configuration option data 41 comprise descriptions oftest configurations, used in the calibration of an implanted medicaldevice 40. Optionally, device configuration option data 41 comprise datagenerated by a device parameter space to patient performance spacemapper 62 (mapper 62). The data are generated, for example, based oncorrelations determined by mapper 62 between settings selected on thedevice (for example, by a configuration controller 61), and resultingeffects on patient 10 in patient performance space measured, forexample, by performance monitor 60A (optionally via one or more sensingmodalities 45).

Configuration controller 61 optionally operates to set operatingconfiguration 42C by means of selections passed to configurationselector 43, via control of programmer 63, and/or optionally operatesvia a separate dedicated input channel.

Arrangements are such that mapper 62 is able to match differentoperating configurations 42C of the device (in device parameter space)to corresponding results in patient performance space (as determined,for example, by performance monitor 60A). Examples of methods forconfiguring device configuration option data 41 are also describedherein, for example, in relation to FIGS. 11A-11B, 12, and/or block 304of FIGS. 9A-9B.

Parametric Configuration of an Implant Device

Reference is now made to FIG. 8A, which schematically represents aparameter space 100 of potential medical implant device parameterconfigurations, from which members of a subset of availableconfigurations 109, 111, 112 are selectable, according to an orderedarrangement of the configurations 109, 111, 112 along a parametricfunction 101A, 101B.

In the terms described in relation to FIGS. 7A-7B, parameter space 100optionally represents a device parameter space, while parametricfunction 101A, 101B optionally represents a patient performance space.

In some embodiments, an implantable medical device 40 comprises a numberof configurable parameters (the number can be a hundred or more), whichare programmed to govern operating characteristics of the device 40 invivo. These configurable parameters are optionally considered ascomprising corresponding components of a vector in a device parameterspace 100. For purposes of illustration, three such components arerepresented in FIG. 8A as corresponding to x, y, and z spatial axes;however, the actual parameter space may have more dimensions (notshown). It is to be understood that the actual number of such componentscan be any number N, according to the number of configurable parameters.

By these conventions, each available device configuration corresponds toan N-dimensional vector indicating to a particular point in anN-dimensional parameter space 100. In FIG. 8A, the three selectedcomponents of a few such points are individually singled out asconfigurations 109, 111, and 112. Hash marks such as hash mark 103correspond to a few additional such configurations. Curve 101A, shownconnecting all these points, gives them an order, stretching betweenconfiguration 109 at one end of curve 101A, to configuration 112 at theother end, and passing through all the configurations 103 and 111 on theway. Curve 101A is optionally considered as a function f(t) ofparametric variable t. Although a continuous curve is shown for purposesof illustration, At) is optionally only defined, for example, atdiscrete configurations such as 109, 111, and 112, and/or as indicatedby hash marks 103.

An alternative representation of f (t) is shown as the graph of line101B. Here, the portion of patient performance space shown comprises onedimension (represented by horizontal distance). The variable t isoptionally considered as corresponding to a patient performance metric,for example, a level of a treatment effect or a level of a side-effect.It is to be understood that this “level” is not necessarily quantified.However, level is preferably defined at least in terms of relativeordering; i.e., there is a progression from more to less of an effect bymotion in a single direction between configuration 109 and configuration112.

In relation to components enumerated in FIG. 7A: in some embodiments ofthe invention, operating configuration 42C is selected from amongconfigurations such as configurations 109, 111, 112 lying along graph101A, 101B. Graph 101A, 101B, representing the collection of all(currently) selectable configurations, optionally corresponds to deviceconfiguration option data 41. Optionally, a setting of configurationselector 43 is what selects operating configuration 42C from one of theselectable configurations lying along graph 101A, 101B. Theconfiguration of the device is optionally considered as beingparametric, insofar as the selection of device parameter settings isdefined to be dependent on a selection of the parameters of a targetpatient performance state.

Device Configuration Option Selection and Ordering

Reference is now made to FIGS. 8B-8E, which schematically represent amedical implant device parameter space 200 and some particular implantdevice configurations 240, 211, 242, 213, within it, together withindications of relative magnitudes of targeted treatment effects 201,201A, 203 and/or of preferably avoided side effects 202B, 202A, withindifferent regions of the parameter space 200, according to someembodiments of the present disclosure.

In some embodiments, configuration of an implanted medical device 40comprises two different activities: selection and/or mapping ofoperating configurations (in device parameter space) to patientperformance space; and governing of configuration movement throughpatient performance space by use of a configuration selector 43.

At each stage, there is optionally a transformation in dimensionality,potentially enabling a variety of different configuration and controlscenarios. For example, control of device configuration is optionallyexerted along a control axis defined with respect to two or moredimensions of patient performance space, while patient performance spaceitself is optionally defined within a larger dimensionality of deviceparameter space. The sections below include descriptions of how aspectsof relatively dimensionality optionally affect mapping.

Single Patient Performance Parameter Configuration Selection

FIGS. 8B and 8C separately show isocontours representing the boundariesof regions of different relative magnitudes of side effects (contours204A, FIG. 8B), and treatment effects (contours 203, FIG. 8C-8D) indifferent regions of device parameter space 200. What is explicitlyshown illustrates two-dimensions of a device parameter space in x and y,overlaid with two different one-dimensional patient performance spacesdefined by the isocontours.

Corresponding effects evaluation scales 202B and 201 are shown inarbitrary units, with higher numbers representing relatively strongereffects. Measurements establishing these contours relating deviceconfigurations to patient results are optionally determined at the timewhen an implanted device is calibrated for use, for example as describedin relation to FIGS. 11A-11B herein. For purposes of explanation, effectmagnitudes are shown as having discrete integral values (within eachband between adjacent isocontours); however, effects are optionallycontinuous in value, or have “values” comprising assignment to one ormore effect categories.

Treatment and/or side effects are optionally subjectively or objectivelyevaluated. For example, a side effect is optionally expressed as areduction in the upper range that a heart rate is allowed to reach(objective, numeric, and optionally continuous or discrete). Optionally,a related side-effect comprises a degree of patient exhaustionassociated with a task, ranked as “none”, “some”, “a lot”, “impossibleto perform” (optionally at least partially subjective, discrete, andaccording to category). Optionally, different effects are not inherentlyrank-ordered (for example, if there are two independent side effectgradients under adjustment control by a single parameter of aconfiguration selector 43, and/or if side effects are described aspurely categorical). However, it is preferable for effects to beassigned some ordering at the time of device calibration so thatadjustment of a selected device configuration can be treated as movementalong a monotonic gradient (for example, a gradient of relativepreference), for example as described in relation to FIG. 8A. In someembodiments, parameter changes comprising differences in two or moredistinct effects are combined and ordered along one ordered listing orgradient, allow single-axis selection.

The axes (x and y) of parameter space 200 represent settings ofarbitrary implant device configuration parameters. For purposes ofdescription, two device configuration parameters (optionally, two groupsof co-varying device configuration parameters) are shown; however, itshould be understood that parameter space 200 optionally comprises anynumber of dimensions corresponding to configuration parameters suitablefor the implant device. For purposes of description, parameter valuesare considered as continuously varying along each axis, however, itshould be understood that in some embodiments the parameter settings arediscreetly variable.

Turning now to the topic of control, reference is made within FIGS.8B-8C to selectable configuration orderings 220C and 222, each of whichcomprises a “control space” that closely corresponds to a respectivepatient parameter space defined by isocontour groups 204A and 203. Sucha relationship between control space and patient parameter space existsin some embodiments, for example, where concern focuses on essentiallyjust one patient performance axis of concern (for example, optimaltreatment level as such, or tolerance to a side effects level).

Configuration ordering 220C shows an set of parameter configurationscovering a range of side effect levels, one configuration per level—butoptionally selected arbitrarily from within that effect level (forexample as shown by configuration ordering 220A). This provides apotential advantage, for example, when it is understood that increasedside-effect and increased treatment effect occur in close correlation,while a target patient performance metric relates to the side effect.Reasons for targeting assessment to a side-effect (in contrast toassessment of the intended treatment effect) could include, for example,relative ease of assessment, and/or a critical requirement to keep acertain side-effect performance metric within a safe acute, chronic,and/or cumulative level.

Such a situation could arise, for example, in the case of an organregulating device (such as a pace maker) which limits organ output (suchas heart rate) to a narrow range to avoid triggering organ imbalance.From this perspective, the best treatment option is optionally “novariation” (most extreme setting); however, the side effect is toprevent normal auto-regulatory behavior in response to activity and/orenvironment. Then the example of range 220C (FIG. 8B), in someembodiments, optionally allows choosing from among predeterminedperformance range widths by providing points along an arbitrary scale ofdevice parameter configurations, including one point at each selectablelevel of side effects. The ordering of the parameter configurations,optionally, is according to increasing/decreasing level of side effects.Control of configuration selection is optionally performed by stepwisemovement through the ordered list of configurations available, forexample as described in relation to FIG. 8A.

Alternatively, (turning now to FIG. 8C), the standpoint is optionallyadopted that there is an optimal treatment level produced by a device,irrespective of side-effects (the case of “additionally” is discussedwith respect to FIG. 8D, hereinbelow). Then selection of a particulardevice configuration optionally comprises moving up or down betweentreatment levels. For example, a threshold level (a maximum heart rate,for example), is preferably set for a device so that the device neverallows an organ to enter a performance regime where some adverse event(such as atrial fibrillation) could occur, while keeping the operatingrange as large as possible. Then range 222 optionally represents deviceconfigurations providing different thresholds for this treatment effect.

Although potential reasons to choose one standpoint (treatment- orside-effect centered) or the other have been described, it can beunderstood from the foregoing closely related examples that the choiceof standpoint is potentially arbitrary; for example, when side effectsare a necessary and direct consequence of treatment effects (and/or viceversa).

Optionally, both standpoints co-exist, potentially without distinction(that is, it is simply understood that more treatment yields more sideeffect).

Dual Patient Performance Parameter Configuration Selection

In some embodiments, treatment effects and side effects are at leastpartially decoupled from one another with respect to the selection ofdevice parameter settings. Optionally, a device according to someembodiments of the current disclosure is configured to take advantage ofthis decoupling in the selection of available device configurations,and/or how device configurations are ordered for controlled selection.

Turning now to FIG. 8D, contour groups 203, 2014A from FIGS. 8B-8C areshown overlaid, with the addition of shading to help demonstraterelationships between the two contour groups. Relatively darker shadingrepresents relatively greater treatment obtained effects compared toside effects produced for each device configuration. For example, thefirst level of shading darker than white is used when both side effectsand treatment effects are ranked the same (e.g., both at level 0, 1, 2,3 . . . ). Increasingly dark shading is used as the magnitude oftreatment effects rises relatively above that of corresponding sideeffects. Since the rankings are arbitrary, no particular significanceapplies to the absolute values shown. However, the pair (0,0) optionallyrepresents no treatment applied, and thus no effects of either type.

In some embodiments, an implant device is provided with a plurality ofselectable pre-defined configurations, for example, configurations 240,211, 242, and 213. Furthermore, the configurations are ordered, as shownby segments 244 connecting the configurations.

The selection and/or ordering of configurations is optionally influencedby what will be a primary focus (but not necessarily a sole focus) ofdecision making in moving along a treatment spectrum in patientperformance space. For example, for devices providing “best if maximal”treatment, moderated mainly by tolerance to side effects: selectingand/or rank-ordering configurations is optionally according todistinctions among side effects produced. For devices and/or situationswhere selecting a balance reflecting a precise treatment level is moreimportant, it is optionally preferred to focus configuration selectionand ordering on distinctions among treatment effects produced.

Furthermore, one device optionally operates within more than one regimeof respective treatment- and side-effects, and criteria for controllingthat operation are optionally different between these regimes. Forexample, one regime optionally includes how the device behaves when thepatient is at rest, and another how the device behaves when the patientis active. According to a potentially shifting balance of concerns ineach domain for patient performance characteristics such as safety,comfort, freedom of activity, etc., a relative emphasis on treatmenteffects or side effects is optionally also different in each domain.

It should be emphasized, moreover, that choice of configurations toinclude in a range, and the organizing of configurations in some orderwithin that range, are distinguishable operations, optionally relying ondifferent criteria. The first operation refers more to determining whatoptions are available with the configured device; the second operationrefers more to how the configured device options are controlled.

Considerations for each of these two operations will now be discussed inturn.

As to the choice of device configurations available for selection: inFIGS. 8B-8D, the locations of selectable device configurations inparameter space 200 (falling along path 244) are shown chosen accordingto a rule by which each distinguished magnitude (level) of treatmenteffects (from 0-9, inclusive) is represented; and moreover, isrepresented by a configuration falling into the lowest side effectslevel available at that treatment effects magnitude. This provides apotential advantage for selecting from among available choices bytreatment effects level. FIG. 8E, in contrast, shows choice by analternative rule where each side effects level (along path 214Bcorresponding to linear path 214A) is represented by a configurationgiving the largest available treatment effects level in its band. Thisprovides a potential advantage for selection from a range ofconfiguration options according to side effects level.

As to ordering of the device configurations for control: optionally(FIG. 8D), the ordering is between a “least treatment effects”configuration 240, and a “most treatment effects” configuration 242. Theordering is indicated by segments along path 244 which join theconfigurations to one another. In FIG. 8E, path 214B joinsconfigurations from “least side effects” to “most side-effects”. Itshould be noted that these rules do not necessarily produce the sameordering even when all configurations available are the same. In asimple case, there would usually be little preference to allow greaterside-effect with less treatment effect, but where there are additionaltrade-offs involved, such a preference might prevail. Optionally,another ordering rule is used; for example a weighted combination oftreatment effects and target effects. In terms of “control space” vs.“patient performance space”, this could comprise defining an controlspace as an oblique line cutting across two or more dimensions ofperformance space. Configuration selection is optionally performed bystepwise movement through the ordered list of configurations available,for example as described in relation to FIGS. 7A and/or 8A.

In the foregoing, the evaluation scales of treatment effects and sideeffects have been treated as being substantially in opposition to oneanother. However, it is possible, in some embodiments, for evaluationscales to simultaneously represent wanted or unwanted effects (forexample, two treatment effects or two side effects which are obtained atleast partially in the alternative). In some embodiments, for example,device configurations provided for selection are optionally selected toobtain the highest available level of a second treatment effect, given aparticular target level of a first treatment effect.

Multiple Patient Performance Parameter Configuration Selection

In the examples of FIGS. 8A-8E, a linear axis of control is providedthrough a one- or two-dimensional patient performance space. It can beunderstood also that there may be more than two evaluation scales forpatient performance that apply to the operation of an implantablemedical device. Optionally, this is dealt with by the use of anyappropriate weighting scheme to make selections of device configurationsavailable for selection, and an ordering among them along whichselection is made.

It is, in the case of two or more evaluation scales, a potentialadvantage for one of the scales to be considered dominant, particularlywith respect to arranging device configurations in an order forselection from, for example, as described in relation to FIG. 8A.

In some embodiments, control is also exercised along a plurality ofaxes.

Reference is now made to FIGS. 8F-8G, which schematically representtwo-dimensional control spaces 260, 270.

For purposes of explanation, the control spaces are shown as comprisinga number of discrete selectable configurations 265. Optionally, however,configuration is continuously selectable along one or more control axes,for example, control axes 263 and/or 264.

In a two- or higher-dimensional control space, there is optionally nolonger a single ordering of selectable configurations 265 with respectto one another. However, edges such as edges 262, 261 optionallyrepresent relative ordering along each axis 263, 264. Optionally,selection is set along two or more axes simultaneously. For example, afirst axis optionally governs a magnitude of treatment effect, while asecond axis optionally governs a relative trade-off between two or moreside-effects.

FIG. 8F suggests control occurring within a more or less isomorphicgrid.

However, this is only one possible control topology. As another example,FIG. 8G illustrates a case where some of the configurations which theoverall extent of the control grid suggests are unavailable for somereason. For example, an unavailable configuration may represent aconfiguration which is physically unavailable to the device, iscontraindicated, and/or is not validated. In some embodiments, this ishandled by implementing a number of control “tracks” (such as controltracks 266A-266D), which at some positions share configuration points,but which are generally separate, and optionally selected among by useof another control axis 272. It should be understood that a selectablecontrol track model is also optionally provided even for a fullypopulated grid. In some embodiments, a plurality of control tracks isprovided which each pass through patient performance space alongindependent (optionally crossing) paths.

For example, the configuration options are optionally selected accordingto different rules (such as described in relation to FIGS. 8A-8E) foreach track. This is a potential advantage, for example, when the patientperformance parameter(s) of greatest concern are at least partiallyundetermined in advance (during device calibration), but become cleareras the patient learns to live with the device, and/or as the clinicalsituation evolves. Optionally, track switching is facilitated by trackssharing one or more device parameter configurations in common, such asdevice configuration 265A.

Implantable Medical Device Configuration Methods

Reference is now made to FIG. 9A, which is a flow chart representing aconfiguration life cycle of an implantable medical device 40, accordingto some embodiments of the present disclosure.

At block 302, in some embodiments, an implantable medical device 302 isimplanted.

At block 304, in some embodiments, device configuration options are set.Sub-operations associated with block 304 are detailed in relation toFIGS. 11A and 11B herein. Optionally, there is a distinction betweeninitial setting of configuration options for the device (described, forexample, in relation to FIG. 11A), and configuration option updates forthe device (described, for example, in relation to FIG. 11B).

At block 306, in some embodiments, patient performance is evaluated.Evaluation of patient performance is described, for example, in relationto FIG. 10 herein. In some embodiments, evaluation of patientperformance is performed by a primary care physician.

At block 314, in some embodiments, the operating configuration 42C ofthe device is adjusted. Adjustment optionally comprises operation of auser interface of a configuration selector 43, for example as describedin relation to FIG. 7A, herein. In general, adjustment of the operatingconfiguration 42C of the device is within a control space coordinated toa patient performance space.

The coordination is optionally such that a certain control settingcorresponds to a certain targeted effect of the implanted medical device40 in patient performance space. Optionally, the coordination is suchthat selection comprising movement in a particular direction in controlspace produces a corresponding movement of the device's effects inpatient performance space. For example, a given direction of controlmovement is optionally tied to increasing how readily a pacing rate of apatient's heart is increased in response to sensed data (e.g.acceleration) indicating activity. Optionally, the technical parametersunderlying this increased sensitivity include a plurality of parameters;for example, one or more of thresholds of acceleration, sensingintegration time, maximum allowable pacing rates, rate of pacingramp-up, etc.

At block 312, in some embodiments, a next patient performance evaluation(that is, a re-entry to the flowchart at block 306) and/or a nextreconfiguration of the device (re-entry to the flowchart at block 304,optionally corresponding to the flowchart of FIG. 11B) is scheduled.

Reference is now made to FIG. 9B, which is a flow chart representing amore particular configuration life cycle of an implantable medicaldevice 40, according to some embodiments of the present disclosure.

In some embodiments, configuration control of an implanted medicaldevice 40 is realized by implementation of a simple decision to operatethe device with more or less of some effect, or with the configurationunchanged. This control scheme corresponds, for example, to control bymoving in one direction or another along a path and/or parametricfunction, for example as described in relation to FIGS. 8A-8E.

Blocks 302, 304, 306, and 312, in some embodiments, occur substantiallyas described in relation to FIG. 9A. Blocks 308-311 comprise an exampleof a more specific implementation of block 314 of FIG. 9A.

At block 308, in some embodiments, a determination is made, based on thepatient performance evaluation of block 306, as to whether or not lessof some effect (treatment effect or side-effect, according to the deviceconfiguration) is needed (that is—the question “is there too much of theeffect?” is answered).

If so, the configuration selection is decremented at block 309(decremented in the direction of reduced effect). Otherwise, at block310, a determination is made as to whether or not more of the effect isneeded (there potentially being too little of it). If so, at block 311,the configuration selection is incremented.

Optionally, these operations are performed by a selection between twobutton presses, for example, “+” and “−”, to change a selected deviceparameter configuration. A potential advantage of this particularlysimple control regime is that it can be fairly easily implemented by aprimary care physician after an introductory familiarization with thedevice. Preferably, the patient performance parameter behind the “toomuch” and “too little” questions is easily determined by the physicianin consultation with the patient and/or based on common test results.

Reference is now made to FIG. 10, which is a flowchart thatschematically represents operations of patient performance evaluation,for example, in the context of block 306 of FIGS. 9A-9B.

In some embodiments, information about patient performance is obtainedfrom any one of three potential sources: implant self-diagnosis 422,patient checkups 424, and device performance checks 426. These can bedistinguished, for example, as information which an implanted device 40determines about itself (block 422), and optionally provides to itselffor further action; information which a physician determines aboutpatient performance in consultation with the patient and/or test resultsoutside the device itself (block 424); and information which a physiciandetermines together with controlled operation of the device (block 426).

At block 422, in some embodiments, implanted medical deviceself-diagnosis is performed. Optionally, self-diagnosis comprisesdetermining (based on sensed patient performance data provided to thedevice) what the performance effects of device operation are for one ormore particular device operating configurations.

Optionally, the self-check operates by comparing the routine operationof the device to the results expected, for example, as establishedduring device calibration.

Optionally, self-diagnosis comprises occasional operation outside theroutine configuration, and monitoring of the result (this is alsodescribed, for example, in relation to block 522 of FIG. 11B).

Optionally, the implanted medical device adjusts itself based onresults.

Additionally or alternatively, it is configured to report status results(for example, detection of changes, calibration skew, etc.) through anappropriate control interface 43A.

At block 424, in some embodiments, a patient checkup is performed. Thepatient checkup optionally comprises any observation of a patient by aphysician or clinic; for example, a test result (e.g., metabolite level,and/or monitoring data), a symptom, vital statistic changes, lifestylesatisfaction, incidence of infrequently triggered events, and/or anotherclinical finding. However, typically, the observation is of aperformance parameter suitable for routine evaluation by a primaryphysician during a routine checkup.

At block 426, in some embodiments, implanted device performance checksare performed. These optionally comprise issuance by the evaluatingphysician of any suitable command to the medical device, coupled toobservation of the results.

Optionally, an implanted medical device makes available a mode whereinit can be set into one or more evaluation configurations. For example,an evaluation mode for a pacing device optionally sets one or morepacing configurations that differ from the baseline configuration.Evaluation optionally comprises verifying that the performance resultsexpected are those actually obtained (for example, by separatemonitoring of heart rate). In some embodiments, no entry into a reservedtest mode is performed; rather, the patient is directly guided through asuite of tests (e.g., exercises) designed to elicit responses from theimplanted device which should be revealed in the observation of one ormore patient performance parameters.

Preferably, the operations of block 422, 424, and 426 are arranged torequire minimal specific expertise from the physician regardingoperation and configuration of the device 40 itself. Preferably, theseoperations chiefly or solely consist of the device adjusting itself, andthe physician interacting as they would normally with the patient inorder to understand the current performance state of the patient.

At block 427, in some embodiments, the data gathered at one or more ofblocks 422, 424, and 426 is evaluated to determine if the implant isoperating within specified and/or targeted parameters.

This is optionally accomplished by use of the device itself (forexample, the device reports on itself as being within or not withinspecifications based on self-test result). If the device is found to besufficiently out of specification, the patient is optionally referred toa device specialist for reconfiguration of the device (block 411).

At block 428, in some embodiments, a determination is made as to whetheror not the configuration of the device should be adjusted (viaconfiguration selector 43). Criteria for adjustment are described, forexample, in relation to block 306 of FIG. 9A.

Reference is now made to FIG. 11A, which is a flowchart thatschematically represents a method of setting available configurationoptions for an implantable medical device, according to some embodimentsof the present disclosure.

At block 511, in some embodiments, an iterating loop is entered in whicha device operating configuration is set, evaluated, changed, andevaluated again.

Optionally, any one or more of several strategies governing theselection is used.

In some embodiments, configuration options are chosen at least in partaccording to one or more clinical targets for the patient, together withan understanding of how a device's parameter settings work together toachieve clinical targets. Optionally, the clinical target is anticipatedto change over time, and configuration options are selected so that newtargets are achieved. For example, if a patient performance effect of adevice is to assist in weight loss (for example, by modulation ofautonomic responses), an initial clinical target is optionally selectedto be a high rate of weight loss, an intermediate clinical target is amore sustainable rate of weight loss, and a long term clinical target ismaintenance of a target weight.

The choice device configuration for achieving a clinical targetoptionally comprises an iterative approach, for example, for deviceswhere inter-patient variability leads to at least some initial lack ofpredictability in the magnitude of the effects of device operation.

A simple, but potentially laborious (or even impractical) strategy is toiteratively select each of a range of possible device configurationswhich are candidates for configuration options, install them on thedevice (for example, using device programmer 63), and evaluate theresult (for example, as described at block 512).

A potentially less intensive procedure comprises selection of a few“landmark” configuration options, evaluating them with respect topatient performance (for example as described in relation to block 512),and then calibrating other configuration options to patient performancebased on their anticipated effects on patient performance relative tothe landmark configurations. This is particularly suited for thecalibration of configuration options where patient performance change isexpected to be substantially monotonic (for example, linear) between twolandmark configurations. It is also possible for more complexconfiguration characteristics to be set this way, for example, accordingto a default mapping between configuration options and patientperformance determined based on experience with other patients, with thesame patient, and/or based on theoretical considerations. Aspects ofthis approach are described, for example, in relation to FIG. 12.

At block 512, in some embodiments, the effects of a configuration set atblock 511 are evaluated in terms of some measure of patient performanceappropriate to the treatment effects and/or side effects which thedevice is expected to produce in the patient. The testing optionallycomprises, for example, any appropriate test and/or indication ofactivity, responsiveness, metabolite level, patient comfort, or otherindication, as appropriate to the type of device implanted. The testingoptionally comprises direct input-output testing (adjust device, measurea resulting change). The testing optionally comprises perturbationand/or stress testing, for example, measurement of a response toexercise, food consumption or fasting, drug injection, or anothermanipulation which tests how an implanted device operates within acertain regime of interest.

In some embodiments, a measure of patient performance used incalibration is different than a measure used as a part of long termdevice operation adjustment.

Optionally, calibrations for the purpose of establishing deviceconfiguration options are performed in a specialist-accessible patientperformance space.

Optionally, the patient performance space which forms a basis foradjustment long-term is based on parameters more suited to theevaluation of a primary care physician, such as vital statistic changes,lifestyle satisfaction, incidence of infrequently triggered events, etc.In some embodiments, the two performance spaces are established in aninitial registration according, for example, to past experience, and/ortheoretical considerations. In some embodiments, a device is calibratedaccording to specialist-accessible patient performance parameters togive a range of device configuration options which are expected toencompass the preferred region of a patient performance space used inlong-term evaluations.

More particularly, during calibration of a device, it may not bepossible, practical, and/or preferred to evaluate patient performanceusing the same patient performance metrics as are available over thecourse of a longer period of time (for example, as available in relationto the operations of block 306). For example, a patient is treated byneuromodulatory stimulation, in some embodiments, to achieve weight lossover a period of several months or more. Over that period, theperformance parameter of weight loss is relatively straightforward tomeasure.

During initial calibration, however—which preferably involves checkingof several configuration options within a few hours to days—this mightnot be practical.

Evaluation of some patient performance characteristics is potentiallydependent on the daily routine of the patient, and/or on how the patientexperiences relative advantages and limitations of different treatmentlevels. For example, a heart patient whose lifestyle requires regularexertion (stair climbing, for example) might be less tolerant oflimitations on maximum heart rate than a patient which is moresedentary. A patient being treated for pain by neuromodulation might notclearly conceive of how a particular tradeoff between reduced pain andside-effect sensations (such as tingling) will affect their normalactivities, until they return to them.

In contrast, it might be practical, during device calibration, to takeadvantage of relatively sophisticated, complex, and/or invasive testprocedures which are not generally available outside of a specialistclinic, are potentially risky, and/or are too resource intensive to usein long-term monitoring. For example, radio imaging is optionally usedto monitor metabolic activity in response to a neuromodulation device.ECG monitoring is optionally used to detect heart activity in responseto stress testing.

Whatever the evaluation method used, a result of the evaluation at block512, in some embodiments, is to place a particular device operationconfiguration (defined in device configuration space) in some patientperformance space.

At block 514, in some embodiments, it is determined whether or not alltest configurations have been evaluated. If not, the next configurationis optionally selected at block 516 (strategies used for this selectionare described in relation to block 511), and flow returns to block 511.

At block 518, in some embodiments, the accumulated data relating deviceconfigurations to patient performance is converted into deviceconfiguration option data 41. Some features of device configurationoption data 41 are described, for example, in relation to FIGS. 7A-7B,herein.

At block 520, in some embodiments, the device configuration option data41 are stored in the device, for example, by use of a programmer 63.

At this stage, the configuration of the device can optionally beunderstood within the following framework:

-   -   A control space is exposed through one or more interface        controls of configuration selector 43. The controls adjust        and/or select a position in this control space.    -   The selection or adjustment in control space indicates a        corresponding position or adjustment in a primary care patient        performance parameter space. This parameter space comprises        measurable patient performance parameters on which future        adjustment of the device will be based.    -   Furthermore, the selection or adjustment in control space        operates to choose an operating configuration 42C, based on the        provided device configuration option data 41.

From an external standpoint, some of the complexity of device operationconfiguration is thereby masked behind relatively simple determinationsand decisions based on patient performance parameters.

Additionally and/or optionally:

-   -   There can be at least one additional “specialist” or calibration        patient performance space. This is optionally used during        initial setup of the device, and/or referred to during        subsequent updates and/or re-calibrations of the device. The        control space exposed through configuration selector 43 may or        may not correspond to the calibration patient performance space.        However, there is preferably enough of a correspondence between        the two types of patient performance spaces that results in one        can be alternatively understood as indicative of likely results        in the other.

Reference is now made to FIG. 11B, which is a flowchart thatschematically represents a method of updating available configurationoptions for an implantable medical device, according to some embodimentsof the present disclosure.

In some embodiments, the calibration of a device 40 is potentiallysubject to change. For example, there may be changes in the clinicalsituation and/or lifestyle of a patient, and/or interactions withroutine activities of a patient not fully appreciated duringcalibration. Optionally, the most relevant patient performance parameter(for example, a rate of weight loss for neurostimulation aimed at weightreduction) is not measurable outside of a period of several weeks ormonths elapsing after the device is initially configured. Optionallythere is a requirement to correct for drift in device operation; forexample, if a quality of stimulation target contact changes over time.

Optionally, re-calibration is performed according to a regularmaintenance schedule, or otherwise as appropriate, for example, asdescribed with respect to block 428 of FIG. 10 (e.g., based on theresults of device diagnostics, and/or care provider observations). Insome embodiments, a device at least partially self-recalibrates fromtime to time based on an internal schedule, observations of increasingskew between expected and measured results, and/or upon receivingcontrol instructions to do so.

At block 522, in some embodiments, device re-calibration begins, and atest configuration is selected. In addition to any one of the teststrategies described in relation to FIG. 11A, an option available fortest configuration strategy comprises comparing current results for thepatient against older calibration test results—all results, or a portionthereof. This is well-adapted to mapping-type calibration described inrelation to FIG. 12 (for example, an old map is transformed as necessaryto create a new one).

In some embodiments, a self-calibrating device is configured to receivedata reflecting one or more patient performance parameters throughsensors (its own, or sensors it connects to). Optionally, these sensorsare used to provide the patient performance data needed for calibration.For example, a self-calibrating device is optionally operable to providea triggering stimulus to an active tissue (muscular or neural tissue,for example), where it is preferable that the triggering stimulus beminimal, that the resulting activity have some particular measurablefeature (duration, latency, or rise time, for example), or where someother quantifiable criterion can be set based on data received fromsensing. Then self-calibration optionally comprises a deliberatevariation of the triggering stimulus or other output (probing output),determination of the response level, and corresponding adjustment sopatient performance and device parameter configuration remain insynchronization.

In some embodiments, this procedure is optionally performed duringinitial setup of the device (for example, as part of the loop of blocks511, 512, 514, and 516 of FIG. 11A). Optionally, this allows the deviceto at least partially “teach itself” about how the device parameterdomain and the patient performance domain align with one another.

It should be understood that where a device is allowed to perform suchself-calibrations, the range of available probing outputs is confined tothose which are considered safe, and/or self-calibration is limited totimes when the patient is in under adequate supervision for themanagement of any unexpected side effect or adverse result.

In some embodiments, there is feedback into the original calibrationprocedure based on adjustments made later in the lifetime of the device.For example, if there is found to be a degree of delayed physiologicaladaptation to device operation (e.g., stimulation by a device becomesmore or less effective over time as a patient's body adapts to it); thecalibration procedure is optionally updated to anticipate this effect.

At block 524, in some embodiments, corresponding patient performance isevaluated. In some embodiments, there is a loop among several testconfigurations and according to test calibration strategy, (for exampleas described in relation to FIG. 11A), but this detail is elided fromFIG. 11B for simplicity of description.

At block 526, in some embodiments, the device configuration options areupdated on the device 40, for example as described in relation to block520 of FIG. 11A.

In some embodiments, the updating optionally comprises theidentification of device configurations which should be excluded fromfuture selection. This can be based on patient-physician interactionsand clinical evaluation, and/or on the device's own self-reporting. Forexample, if the device has recorded a triggering event (such as an epochof atrial fibrillation) which occurred during device operation undersome particular configuration, that configuration is optionally flaggedfor avoidance in future selections. In some embodiments, this allows thedefinition of one or more “red zones”, which potentially comprise and/orallow triggering conditions specific to the individual patient.

Reference is now made to FIG. 12, which schematically representsconversion of a default mapping 602A of device parameter space topatient performance space to a mapping 604A applicable to a particularpatient, according to some embodiments of the present disclosure.

In some embodiments (for example, as described in relation to block 518of FIG. 11A herein), determination of device configuration option datacomprises conversion of a default mapping 602A of a device parameterspace to patient performance space to a mapping 604A usable with aparticular patient. A potential advantage of this approach is to reduceconfiguration testing required with each individual patient, while stillproviding a large number of usable options for adjustment.

Default mapping 602A, in some embodiments, optionally comprises an arrayof device configuration options (including options 612A, 603A, forexample), each corresponding to a particular operating configuration ofthe device, as well as at least a relative location in patientperformance space. Default mapping 602A is optionally developed, forexample, based on data gathered from one or more patients, oninterpolations and/or extrapolations from this data, and/or fromrelative effects expected based on knowledge of the effects of one ormore device parameter settings. Optionally, there are a plurality ofdefault mapping “templates” available, each suited to a differentclinical situation; optionally, the correct default mapping is selectedbased on characteristics of the patient (age, weight, gender, and/ordisease state, for example), and/or based on which default mapping seemsmost appropriate based on test results obtained during calibrationitself.

The mapping to patient performance space is optionally only relative.That is: there is not necessarily a particular patient performanceexpectation defined by a location within the default mapping; rather,what the default mapping defines is how performance changes amongdifferent device configuration options. For purposes of illustration,what is shown in FIG. 12 comprises discretely mapped deviceconfigurations. However, it should be understood that mapping isoptionally continuous and/or discontinuous.

In some embodiments, conversion of default mapping 602A to a mapping604A usable within the performance space of a particular patient isperformed by testing one or more landmark configurations (for example,configuration 603A, and/or other configurations marked by dark sphereson default mapping 602A), and observing actual patient performanceresults, for example as described in relation to FIG. 11A. This directlydefines positions in patient performance space such as configuration603B in mapping 604A (indicated as identical in device configuration toconfiguration 603A by connecting line 603).

Optionally, these test configuration mappings define a transformation bywhich other configuration conversions, such as between configuration612A and 612B are performed. Optionally, patient performance inconfiguration mapping regions (such as region 606A) outside the space ofthe transformed default mapping is determined by actual testing, and/orby extrapolation. Optionally, part of the default mapping 602A (such asregion 607) does not map into patient performance space, for example,due to the particular physiology of the patient.

In some embodiments, occasional re-calibration of the relationship ofdevice configurations to patient performance follows a similar model.For example, mapping 602A optionally comprises a current mapping of aparticular patient's performance space to available device configurationoptions, and this mapping is converted to new mapping based onre-calibration, for example as described in relation to FIG. 11B.

General

As used herein with reference to quantity or value, the term “about”means “within ±10% of”.

The terms “comprises”, “comprising”, “includes”, “including”, “having”and their conjugates mean: “including but not limited to”.

The term “consisting of” means: “including and limited to”.

The term “consisting essentially of” means that the composition, methodor structure may include additional ingredients, steps and/or parts, butonly if the additional ingredients, steps and/or parts do not materiallyalter the basic and novel characteristics of the claimed composition,method or structure.

As used herein, the singular form “a”, “an” and “the” include pluralreferences unless the context clearly dictates otherwise. For example,the term “a compound” or “at least one compound” may include a pluralityof compounds, including mixtures thereof.

The words “example” and “exemplary” are used herein to mean “serving asan example, instance or illustration”. Any embodiment described as an“example” or “exemplary” is not necessarily to be construed as preferredor advantageous over other embodiments and/or to exclude theincorporation of features from other embodiments.

The word “optionally” is used herein to mean “is provided in someembodiments and not provided in other embodiments”. Any particularembodiment of the invention may include a plurality of “optional”features except insofar as such features conflict.

As used herein the term “method” refers to manners, means, techniquesand procedures for accomplishing a given task including, but not limitedto, those manners, means, techniques and procedures either known to, orreadily developed from known manners, means, techniques and proceduresby practitioners of the chemical, pharmacological, biological,biochemical and medical arts.

As used herein, the term “treating” includes abrogating, substantiallyinhibiting, slowing or reversing the progression of a condition,substantially ameliorating clinical or aesthetical symptoms of acondition or substantially preventing the appearance of clinical oraesthetical symptoms of a condition.

Throughout this application, embodiments of this invention may bepresented with reference to a range format. It should be understood thatthe description in range format is merely for convenience and brevityand should not be construed as an inflexible limitation on the scope ofthe invention. Accordingly, the description of a range should beconsidered to have specifically disclosed all the possible subranges aswell as individual numerical values within that range. For example,description of a range such as “from 1 to 6” should be considered tohave specifically disclosed subranges such as “from 1 to 3”, “from 1 to4”, “from 1 to 5”, “from 2 to 4”, “from 2 to 6”, “from 3 to 6”, etc.; aswell as individual numbers within that range, for example, 1, 2, 3, 4,5, and 6. This applies regardless of the breadth of the range.

Whenever a numerical range is indicated herein (for example “10-15”, “10to 15”, or any pair of numbers linked by these another such rangeindication), it is meant to include any number (fractional or integral)within the indicated range limits, including the range limits, unlessthe context clearly dictates otherwise. The phrases“range/ranging/ranges between” a first indicate number and a secondindicate number and “range/ranging/ranges from” a first indicate number“to”, “up to”, “until” or “through” (or another such range-indicatingterm) a second indicate number are used herein interchangeably and aremeant to include the first and second indicated numbers and all thefractional and integral numbers therebetween.

Although the invention has been described in conjunction with specificembodiments thereof, it is evident that many alternatives, modificationsand variations will be apparent to those skilled in the art.Accordingly, it is intended to embrace all such alternatives,modifications and variations that fall within the spirit and broad scopeof the appended claims.

It is the intent of the Applicant(s) that all publications, patents andpatent applications referred to in this specification are to beincorporated in their entirety by reference into the specification, asif each individual publication, patent or patent application wasspecifically and individually noted when referenced that it is to beincorporated herein by reference. In addition, citation oridentification of any reference in this application shall not beconstrued as an admission that such reference is available as prior artto the present invention. To the extent that section headings are used,they should not be construed as necessarily limiting. In addition, anypriority document(s) of this application is/are hereby incorporatedherein by reference in its/their entirety.

It is appreciated that certain features of the invention, which are, forclarity, described in the context of separate embodiments, may also beprovided in combination in a single embodiment. Conversely, variousfeatures of the invention, which are, for brevity, described in thecontext of a single embodiment, may also be provided separately or inany suitable subcombination or as suitable in any other describedembodiment of the invention. Certain features described in the contextof various embodiments are not to be considered essential features ofthose embodiments, unless the embodiment is inoperative without thoseelements.

What is claimed is:
 1. An implantable medical device system supportingconfiguration by a primary care physician, comprising: a data storeconfigured to receive and store a plurality of inactive technicalparameter sets for use with the implantable medical device; and aselection interface for selecting from among the inactive technicalparameter sets and activating at least one of them; wherein theimplanted medical device provides access allowing parameter setactivation based on recognition of one of a plurality of access keys,and the access is allowed based on which access key is of the pluralityof access keys is recognized.
 2. The implantable medical device systemof claim 1, wherein the data store indexes the technical parameter setsaccording to a parameter of their effect on patient performance, and theselection interface presents inactive technical parameter sets forselection according to the index.
 3. The implantable medical devicesystem of claim 1, wherein the data store is integrated with theimplanted medical device.
 4. The implantable medical device system ofclaim 1, wherein the access key does not give access to modify theinactive technical parameter sets of the data store.
 5. The implantablemedical device system of claim 1, wherein the access key comprises analphanumerically represented key.
 6. The implantable medical devicesystem of claim 1, wherein the access key comprises a cryptographic key.7. The implantable medical device system of claim 1, wherein the accesskey comprises a charger device.
 8. The implantable medical device systemof claim 1, wherein the access key comprises the data store.
 9. Theimplantable medical device system of claim 1, wherein operation of theselection interface comprises entering data about the operation ofanother implantable medical device of the patient.
 10. The implantablemedical device system of claim 1, wherein operation of the selectioninterface comprises entering data about a medicament prescription of thepatient.
 11. A method of associating an implanted medical device to anon-implanting referring health care provider, comprising: providing thereferring health care provider with one of a plurality of device accesskeys; configuring the implanted medical device to allow access toactivate an inactive technical parameter set of the device, based onrecognizing of the device access key, including identifying which accesskey of the plurality of access keys is recognized.
 12. The method ofclaim 11, wherein the implanted medical device is configured to allowselection of the inactive technical parameter set being activated fromamong a plurality of technical parameter sets preconfigured for use withthe implantable medical device.
 13. The method of claim 12, wherein theconfiguring comprises receiving an identifier of the device access keyfrom the referring health care provider, and configuring the device torecognize the identifier.
 14. The method of claim 11, wherein theconfiguring comprises the referring health care provider configuring thedevice to recognize an identifier of the device access key.
 15. Themethod of any one of claims 11, wherein activation of the inactivetechnical parameter set enables an inactive treatment function of theimplanted medical device.
 16. The method of claim 15, comprising lockingthe device to inactivate the inactive technical parameter set untilaccessed by the device access key.
 17. The method of claim 11, whereinthe device access key comprises a charging mechanism for charging theimplanted medical device.
 18. The method of claim 11, wherein the deviceaccess key is limited in a number of uses.
 19. The method of claim 11,wherein the device access key comprises at least one of an alphanumericcode and a cryptographic key.
 20. An implantable medical deviceconfigured to convert from an unmanaged post-implantation state to amanaged post-implantation state upon activation of a state changingfunction by a primary care physician, wherein the managedpost-implantation state allows activation of a treatment function notavailable in the unmanaged post-implantation state.